AccuDiag™

Green Diluent for IFA | GDILUENT | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A FDA: N/A Detection Type: N/A Assay Time: N/A Sensitivity/ Specificity: N/A

AccuDiag™ Toxoplasma IgM (T. Gondii) IFA Kit | 431508-MD | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Qualitative/ Semi- Quantitative Assay Time: ~110 min Sensitivity/ Specificity: 1

AccuDiag™ Toxoplasma IgG (T. Gondii) IFA Kit | 431508-GD | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Qualitative/ Semi- Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ Varicella-Zoster Virus IgG IFA Kit | 421010-G | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ Measles IgG IFA Kit | 250611D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Qualitative/ Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ EBV-NA IgG IFA Kit | 401010-NA | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ EBV-VCA IgM IFA Kit | 401005-MD | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~90 min Sensitivity/ Specificity: 1

AccuDiag™ EBV-VCA IgG IFA Kit | 401010-G | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ HSV-2 IgG IFA Kit | 391010-G | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ HSV-1 IgG IFA Kit | 381010-G | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ CMV IgM IFA Kit | 371010-M | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ CMV IgG IFA Kit | 371010-G | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ B. burgdorferi (Lyme Disease) IgG/IgM IFA Kit | 361010- G/MD | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ FTA-ABS (Syphilis) IFA Kit | 351010 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~130 min Sensitivity/ Specificity: 1

AccuDiag™ FTA-ABS (Syphilis) Titratable IFA Kit | 351010-T | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~130 min Sensitivity/ Specificity: 1

AccuDiag™ FTA-ABS Double Stain (Syphilis) IFA Kit | 351010-DS | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~115 min Sensitivity/ Specificity: 1

AccuDiag™ Legionella Antibody IFA Kit (Group 1-6) | 331008-6D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ nDNA IFA Kit | 320608D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Qualitative/ Semi- Quantitative Assay Time: ~80 min Sensitivity/ Specificity: N/A

AccuDiag™ ASA (Anti-skin Antibody) IFA Kit | 280806D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~85 min Sensitivity/ Specificity: 1

AccuDiag™ ATA (Anti-thyroid Antibody) IFA Kit | 270806D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~85 min Sensitivity/ Specificity: 1

AccuDiag™ ASMA (Anti-smooth muscle Antibody) IFA Kit | 260806D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ AAS Mouse Kidney/Stomach/ Liver Tissue Test System IFA Kit | 250610D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ AAS Rat Kidney/Stomach/Liver Tissue Test System IFA Kit | 250609D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ AAS Rat Kidney/Stomach Tissue Test System IFA Kit | 250608D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ AMA (Anti-mitochondrial Antibody) IFA Kit | 240806D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA HEP-2 IFA Kit with Evans Blue | 230512DE | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA HEP-2 IFA Kit with Evans Blue | 231005DE | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA HEP-2 IFA Kit | 230512D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA HEP-2 IFA Kit | 231005D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi- Quantitative/ Qualitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA Mouse Kidney IFA Kit | 220708D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ ANA Rat Liver IFA Kit | 210708D | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes FDA: Cleared Detection Type: Semi-Quantitative Assay Time: ~80 min Sensitivity/ Specificity: 1

AccuDiag™ Thyroglubulin Cancer (New) | 1421-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: CE IVD: IVD Detection Type: Quantitative Assay Time: See insert Sensitivity/ Specificity: See insert

AccuDiag™ Hepcidin 25 (bioactive) HS (New) | 1744-6 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: Research Detection Type: Quantitative Assay Time: 110 min Sensitivity/ Specificity: See insert

AccuDiag™ C1 Esterase (New) | 1925-45 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: Research Detection Type: Quantitative Assay Time: 180 min Sensitivity/ Specificity: 1.875 ng/ml

AccuDiag™ ACTH (New) | 2044-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: Research Detection Type: Quantitative Assay Time: 5 hours Sensitivity/ Specificity: 1 pg/ml

AccuDiag™ Reverse T3 (New) | 3145-38 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: 0.009 ng/ml/100%

AccuDiag™ T3 Uptake | 3176-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: N/A

AccuDiag™ Free T3 | 3148-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: 0.05pg/mL / 97%

AccuDiag™ Free T4 | 3146-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: 0.314 ng/dL / 97%

AccuDiag™ TSH Ultra-Sensitive | 3123-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 140 min Sensitivity/ Specificity: 0.05 µlU/mL/ 96%

AccuDiag™ TSH Ultra-Sensitive | 3123-16 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 170 min Sensitivity/ Specificity: 0.05 µlU/mL/ 96%

AccuDiag™ TSH | 3122-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.2 µIU/ml / 97.5%

AccuDiag™ TSH | 3122-16 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.2 µlU/mL/ 100%

AccuDiag™ T5 | 3149-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.5 µg/dl / 96%

AccuDiag™ T4 | 3149-16 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.5 µg/dl / 96.3%

AccuDiag™ T4 | 3144-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.2ng/mL / 96.8%

AccuDiag™ T3 | 3144-16 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 95 min Sensitivity/ Specificity: 0.2ng/mL / 96.3%

AccuDiag™ Dihydro-Testosterone (DHT) | 2042-38 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 95 min Sensitivity/ Specificity: 6.0 pg/ml / 100%

AccuDiag™ 17-alpha-OH Progesterone | 1292-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 110 min Sensitivity/ Specificity: 0.05 ng/ml / 100%

AccuDiag™ Free Estriol | 3171-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 110 min Sensitivity/ Specificity: 0.03 ng/ml / 100%

AccuDiag™ Estrone (New) | 2066-38 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 95 min Sensitivity/ Specificity: 3pg/ml / 100%

AccuDiag™ Androstenedione | 1038-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: ~50 min Sensitivity/ Specificity: 0.04 ng/mL

AccuDiag™ Free Testosterone | 2925-17 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 0.06 pg/ml / 100%

AccuDiag™ Free Testosterone | 2925-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: N/A

AccuDiag™ Testosterone | 2095-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 125 min Sensitivity/ Specificity: 0.05 ng/mL / 95%

AccuDiag™ Progesterone | 2077-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 125 min Sensitivity/ Specificity: 0.06 ng/mL / 97%

AccuDiag™ Aldosterone | 4230-6 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 10.0 pg/ml / 100%

AccuDiag™ DHEA | 2056-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 0.10 ng/ml / Ins.

AccuDiag™ DHEA | 2056-6 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 0.07 ng/ml / Ins.

AccuDiag™ DHEA-S | 2055-17 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 0.03 µg/ml/ 90%

AccuDiag™ DHEA-S | 2055-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 110 min Sensitivity/ Specificity: 0.03 µg/ml/ 90%

AccuDiag™ Estradiol | 2046-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 125 min Sensitivity/ Specificity: 10 pg/ml / 97%

AccuDiag™ Cortisol | 6101-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 105 min Sensitivity/ Specificity: 0.37 µg/ml/ 95%

AccuDiag™ Cortisol Saliva | 7101-38 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 80 min Sensitivity/ Specificity: 1.0 ng/ml / 100%

AccuDiag™ Testosterone Saliva | 7095-38 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 125 min Sensitivity/ Specificity: 1 pg/ml / 100%

AccuDiag™ Campylobacter (Fecal) | 8320-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 50 min Sensitivity/ Specificity: 77 / 100 %

AccuDiag™ Crypto/Giardia Ag Combo | 8310-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 99 / 100 %

AccuDiag™ Giardia | 8304-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 /100 %

AccuDiag™ E. Coli Verotoxin (Fecal) | 8303-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 100 min Sensitivity/ Specificity: 100 / 99 %

AccuDiag™ E. histolytica/dispar | 8307-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 45 min Sensitivity/ Specificity: 88 /100 %

AccuDiag™ Cryptosporidium (Fecal) | 8301-3 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 100 %

AccuDiag™ Filaria IgG4 (New) | 8211-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: N/A

AccuDiag™ Ascaris IgG | 8212-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 100 / 96 %

AccuDiag™ Trichinella IgG | 8207-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 80 min Sensitivity/ Specificity: 100 / 100 %

AccuDiag™ Toxocara IgG (New) | 8216-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Semi- Quantitative Assay Time: 60 min Sensitivity/ Specificity: N/A

AccuDiag™ Toxocara IgM | 8217-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 25 min Sensitivity/ Specificity: 87.5 / 93.3 %

AccuDiag™ Toxocara IgG | 8206-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 87.5 / 93.3 %

AccuDiag™ Leptospira IgG & IgM Minimum Order is 50 kits | 8210-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 88.7 / 87.5 %

AccuDiag™ Leptospira IgM Minimum Order is 50 kits | 8208-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 85 min Sensitivity/ Specificity: 100 / 100 %

AccuDiag™ Leptospira IgG Minimum Order is 50 kits. | 8204-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: IVD Detection Type: Qualitative Assay Time: 85 min Sensitivity/ Specificity: 80%/87.5%

AccuDiag™ Scrub typhus IgM | 8405-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: N/A

AccuDiag™ Scrub typhus IgG | 8406-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: N/A

AccuDiag™ Chagas | 8100-33 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: 100/98.7%

AccuDiag™ Chagas | 8100-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 96 / 97 %

AccuDiag™ Strongyloides IgG | 8319-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 100 / 100 %

AccuDiag™ Schistosoma IgG | 8209-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 25 min Sensitivity/ Specificity: 100 / 85 %

AccuDiag™ Fasciola gigantica (New) | 8120-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: See insert

AccuDiag™ Fasciola IgM | 8121-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 25 min Sensitivity/ Specificity: 100 / 100 %4

AccuDiag™ Fasciola IgG | 8119-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 100 / 100 %

AccuDiag™ Leishmania | 8203-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 25 min Sensitivity/ Specificity: 97 / 84 %

AccuDiag™ Leishmania | 8203-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: 100% / 99%

AccuDiag™ Echinococcus IgG | 8202-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 97.9 / 91.7 %

AccuDiag™ E. histolytica IgG (Amebiasis) | 8201-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 20 min Sensitivity/ Specificity: 92 / 100 %

AccuDiag™ Cysticercosis IgG (T.Solium) | 8105-35 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Semi- quantitative Assay Time: 20 min Sensitivity/ Specificity: 88 / 96%

AccuDiag™ N-17OHPG (Neo Natal 17- OH progesterone) (New) | 4116-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 135 min Sensitivity/ Specificity: 28.6 nmol/L

AccuDiag™ N-TBG (NeoNatal TBG) (New) | 4115-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 135 min Sensitivity/ Specificity: 0.60 ng/ml

AccuDiag™ NNT4 (NeoNatal T4) | 3150-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 155 min Sensitivity/ Specificity: 0.05 µg/dL / 97%

AccuDiag™ NTSH ( NeoNatal TSH) | 3124-15 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 95 min Sensitivity/ Specificity: 0.2 µlU/mL / 100%

AccuDiag™ Salmonella typhi IgM | 6151-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 50 min Sensitivity/ Specificity: N/A