Duns Number:064608573
Device Description: Phosphorus inorganic - ADVIA Chem. - Conc. RGT - 6x1700 tests
Catalog Number
6860523
Brand Name
ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated
Version/Model Number
10283347
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K991576
Product Code
CEO
Product Code Name
Phosphomolybdate (colorimetric), inorganic phosphorus
Public Device Record Key
12f15dd8-a0bf-4f33-b83b-20dd3b75d80d
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 |