Primary Device ID | 07613336129746 |
NIH Device Record Key | ddbd1f3b-98e9-4b9b-876e-c359ae1513b6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PreciControl Anti-HAV II |
Version Model Number | 08086672190 |
Catalog Number | 08086672190 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613336129746 [Primary] |
QCH | Assayed quality control material for clinical microbiology assays |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-08 |
Device Publish Date | 2019-09-30 |
07613336227763 - Sodium electrode | 2025-03-13 |
07613336227770 - Potassium electrode | 2025-03-13 |
07613336227787 - Chloride electrode | 2025-03-13 |
07613336227794 - Reference electrode | 2025-03-13 |
07613336183045 - PreciControl Release HIV Gen II | 2025-02-27 |
07613336228487 - Elecsys Anti-HBc II | 2025-02-27 |
07613336228500 - Elecsys HIV Duo | 2025-02-27 |
07613336183212 - PreciControl HIV Gen II | 2025-02-27 |