Duns Number:064608573
Device Description: CRP - ADVIA Chem. - RGT - 2x220 tests
Catalog Number
B01-4800-01
Brand Name
ADVIA® Chemistry wr CRP Wide Range C-Reactive Protein Reagents
Version/Model Number
10318309
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2022
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
K001009
Product Code
DCK
Product Code Name
C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
Public Device Record Key
a61d6380-3759-4100-828c-fee9ab47351e
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
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 |