Duns Number:064608573
Device Description: ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Catalog Number
6860477
Brand Name
ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents
Version/Model Number
10283342
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 03, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CKA
Product Code Name
NADH OXIDATION/NAD REDUCTION, ALT/SGPT
Public Device Record Key
19e09659-391a-4969-a2d6-eaf2167b8113
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
October 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |