Primary Device ID | 07613336218440 |
NIH Device Record Key | ab07c152-6d3f-4c60-b6ff-8d21589eb54e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Elecsys Rubella IgM |
Version Model Number | 09755837190 |
Catalog Number | 09755837190 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613336218440 [Primary] |
LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-01 |
Device Publish Date | 2024-10-24 |
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 |