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%