Primary Device ID | 07613336179444 |
NIH Device Record Key | beacbf0a-e07e-4924-af11-df74bba8bf57 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Elecsys Anti-SARS-CoV 2 |
Version Model Number | 09203079190 |
Catalog Number | 09203079190 |
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 | 07613336179444 [Primary] |
QVP | SARS-CoV-2 serology test |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-30 |
Device Publish Date | 2025-07-22 |
07613336179444 - Elecsys Anti-SARS-CoV 2 | 2025-07-30 |
07613336179444 - Elecsys Anti-SARS-CoV 2 | 2025-07-30 |
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07613336232194 - Ionify ControlSet Steroids and Vitamin D | 2025-07-03 |
07613336232149 - Ionify Vitamin D 25 | 2025-06-12 |
04015630924288 - sFlT-1 CalSet | 2025-04-15 |
04015630925407 - CalSet PlGF | 2025-04-15 |