Endocrinology Medical Devices Page: 21
| BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests hCG, serum, qualitative | Urine hCG by visual color comparison tests | | View Complexity |
| Bionike A/Q Pregnancy Test hCG, serum, qualitative | Urine hCG by visual color comparison tests | | View Complexity |
| Bionike A/Q Pregnancy Test for Urine Urine hCG by visual color comparison tests | | CLIA WAIVED |
| BIONIKE ADVANCED QUALITY PREGNANCY TEST Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bioscreen Medical One Step Cassette Style hCG Urine (Home) Pregnancy Test Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bioscreen Medical One Step hCG Pregnancy Urine Test Cassette Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bioscreen Medical One Step hCG Pregnancy Urine Test Strip Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Cassette hCG, serum, qualitative | Urine hCG by visual color comparison tests | | View Complexity |
| Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Strip hCG, serum, qualitative | Urine hCG by visual color comparison tests | | View Complexity |
| Bioscreen Medical One Step Midstream Style hCG Urine (Home) Pregnancy Test Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Bioscreen Medical One Step Strip Style hCG Urine (Home) Pregnancy Test Urine hCG by visual color comparison tests | | CLIA WAIVED |
| BioStar Acceava hCG Urine Basic Test Urine hCG by visual color comparison tests | | CLIA WAIVED |
| BioStar Acceava hCG-Urine Test Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Biostride Free T4 EIA Thyroxine, free (FT4) | | HIGH |
| Biosyn Gastrin EIA Gastrin | | HIGH |
| BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE hCG, serum, qualitative | hCG, Urine | | View Complexity |
| BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP hCG, serum, qualitative | hCG, Urine | | View Complexity |
| BIOTECH ATLANTIC INC UNIMARK ONE STEP HOME PREGNANCY TEST DEVICE hCG, Urine | | CLIA WAIVED |
| BioTech Atlantic UniStep HCG Pregnancy Test Device Urine hCG by visual color comparison tests | | CLIA WAIVED |
| BioTech Atlantic UniStep HCG Pregnancy Test Strips Urine hCG by visual color comparison tests | | CLIA WAIVED |
| Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device Follicle stimulating hormone (FSH) | | CLIA WAIVED |
| Biotecx Laboratories OptiCoat T3 Triiodothyronine (T3) | | HIGH |
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