Duns Number:064608573
Device Description: CO2 enzymatic - ADVIA Chem. - RGT - 1200 tests
Catalog Number
7506781
Brand Name
ADVIA® Chemistry CO2_L Carbon Dioxide Liquid Reagents
Version/Model Number
10326480
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 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
K100289,K100289
Product Code
KHS
Product Code Name
ENZYMATIC, CARBON-DIOXIDE
Public Device Record Key
5330c066-68d4-4fab-b474-355f5c9b86d3
Public Version Date
November 18, 2021
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 |