Duns Number:064608573
Device Description: CLINITEK® Microalbumin 2 Reagent Strips are firm plastic strips that contain two reagent p CLINITEK® Microalbumin 2 Reagent Strips are firm plastic strips that contain two reagent pads that test for albumin and creatinine in urine.
Catalog Number
A2083C24
Brand Name
CLINITEK® Microalbumin 2 Reagent Strips
Version/Model Number
10317439
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K972706,K972706
Product Code
CJG
Product Code Name
TETRABROMO-M-CRESOLSULFONPHTHALEIN, ALBUMIN
Public Device Record Key
e895ddf4-4dc4-4d0d-9323-b69950169e96
Public Version Date
December 22, 2021
Public Version Number
6
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 |