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 |
07613336217665 - Elecsys Total PSA | 2024-11-01 |
07613336217672 - Elecsys free PSA | 2024-11-01 |
07613336218440 - Elecsys Rubella IgM | 2024-11-01 |
07613336218440 - Elecsys Rubella IgM | 2024-11-01 |
07613336217146 - Elecsys AFP | 2024-10-30 |
07613336218426 - Elecsys Prolactin II | 2024-10-16 |
07613336160367 - Elecsys Anti-HBs II | 2024-10-10 |
07613336230367 - Elecsys Anti-HBs II | 2024-08-28 |
07613336217801 - Elecsys FSH | 2024-08-27 |