Duns Number:064608573
Device Description: A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge.
Catalog Number
10888741
Brand Name
DCA® Systems Hemoglobin A1c capillary holders
Version/Model Number
10888741
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
K951361,K951361
Product Code
LCP
Product Code Name
ASSAY, GLYCOSYLATED HEMOGLOBIN
Public Device Record Key
2ef1673d-40cf-4698-9cb1-d6655145c17f
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
March 01, 2017
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 |