Primary Device ID | 07613336130537 |
NIH Device Record Key | a0fa8aa8-a3ec-45e5-9886-7481bc20cb96 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aspartate Aminotransferase acc. to IFCC II |
Version Model Number | 08104719190 |
Catalog Number | 08104719190 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613336130537 [Primary] |
CIT | Nadh oxidation/nad reduction, ast/sgot |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-22 |
Device Publish Date | 2024-01-12 |
07613336182994 - PreciControl Release HBsAg II | 2024-11-15 |
07613336228456 - Elecsys HBsAg II | 2024-11-15 |
07613336183137 - Elecsys HBsAg II Auto Confirm | 2024-11-15 |
07613336183168 - PreciControl HBsAg II | 2024-11-15 |
07613336183236 - PreciControl HBsAg II Auto Confirm | 2024-11-15 |
07613336234402 - navify® Lab Operations | 2024-11-05 |
07613336217665 - Elecsys Total PSA | 2024-11-01 |
07613336217672 - Elecsys free PSA | 2024-11-01 |