| Primary Device ID | 00850392007275 |
| NIH Device Record Key | e01d8b61-9210-4b9b-a870-2a9ef3c9dd2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioCheck hCG EIA Test Kit |
| Version Model Number | BC-1027 |
| Catalog Number | BC-1027 |
| Company DUNS | 171857493 |
| Company Name | BIOCHECK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com | |
| Phone | (650)573-1968 |
| info@biocheckinc.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850392007275 [Primary] |
| JHI | Visual, Pregnancy Hcg, Prescription Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-16 |
| Device Publish Date | 2019-10-08 |
| 00850392007015 - BioCheck TSH EIA Test Kit | 2019-10-16 The BioCheck TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration |
| 00850392007039 - BioCheck U-TSH EIA Test Kit | 2019-10-16 The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentratio |
| 00850392007053 - BioCheck T3 EIA Test Kit | 2019-10-16 The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human seru |
| 00850392007077 - BioCheck T4 EIA Test Kit | 2019-10-16 The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum |
| 00850392007176 - BioCheck Myoglobin EIA Test Kit | 2019-10-16 The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum. |
| 00850392007190 - BioCheck High Sensitive CRP EIA Test Kit | 2019-10-16 BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum. |
| 00850392007251 - BioCheck Human Ferritin EIA Test Kit | 2019-10-16 The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin in human serum. |
| 00850392007275 - BioCheck hCG EIA Test Kit | 2019-10-16The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. |
| 00850392007275 - BioCheck hCG EIA Test Kit | 2019-10-16 The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration |