| Primary Device ID | 00810042683174 |
| NIH Device Record Key | 0bac29b3-81dc-4b13-9925-caa48fd0ca3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pregnancy-Skreen |
| Version Model Number | 18003155 |
| Company DUNS | 028007698 |
| Company Name | BIOCHEMICAL DIAGNOSTICS 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| 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 |
| 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 | 00810042683174 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
| 00850004812242 | Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox |
| 00810042681156 | JANT HCG 4mL Kit |
| 00810042681095 | CONSULT HCG 4mL KIT |
| 00810042681088 | Cardinal HCG 4mL Kit |
| 00810042681071 | ALERE HCG 4mL KIT |
| 00810042681415 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL |
| 00810042681408 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL |
| 00810042681392 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL |
| 00810042681385 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL |
| 00810042681347 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit |
| 00810042682900 | PREGNANCY SKREEN Custom hCG Serum 4mL |
| 00810042682894 | PREGNANCY SKREEN Custom hCG Serum 5mL |
| 00810042683174 | hCG Low Positive/Negative Urine 2x5mL Kitbox |
| 00810042683181 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX |