Primary Device ID | 03607360047590 |
NIH Device Record Key | c2b72502-dd2d-4f05-ac17-6edc4813f2d4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hb AFSA2 CONTROL (5) |
Version Model Number | 4759 |
Catalog Number | 4759 |
Company DUNS | 276801933 |
Company Name | SEBIA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 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 | 03607360047590 [Primary] |
JCM | Control, Hemoglobin, Abnormal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-04 |
Device Publish Date | 2023-07-27 |
03607360012444 - CAPILLARYS 3 DBS | 2024-05-08 INSTRUMENT |
03607360025062 - CAPI 3 NEONAT Hb | 2024-05-08 |
03607360025635 - CAPI 3 NEONAT HEMOLYSING SOLUTION | 2024-05-08 |
03607360025789 - CAPILLARYS 3 DBS MICROPLATES | 2024-05-08 MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES |
03607360047576 - CAPI 3 NEONAT Hb AF Control | 2024-05-08 |
03607360047927 - Hb AFSC Control | 2024-05-08 |
03607360026014 - ANTISERA CAPI 3 IT (10) | 2023-12-07 |
03607360026021 - Sample Diluent CAPI 3 IT (10) | 2023-12-07 |