Primary Device ID | 07613336208373 |
NIH Device Record Key | 5882084a-d30e-45d0-ab0c-b0f24c35ce24 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CalCheck Phospho-Tau (181P) |
Version Model Number | 07546424190 |
Catalog Number | 07546424190 |
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 | false |
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 | 07613336208373 [Primary] |
JJX | Single (specified) analyte controls (assayed and unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-09-13 |
Device Publish Date | 2022-12-13 |
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