Primary Device ID | 00810042681392 |
NIH Device Record Key | 52ca9d8d-1da7-4cb9-b7fa-84796d7bb3ed |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pregnancy-Skreen |
Version Model Number | Custom QC23 |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810042681392 [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 | 2020-03-02 |
Device Publish Date | 2020-02-21 |
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 |