Duns Number:048144997
Device Description: This product is for the purpose of calibrating results in the quantitative determination o
Catalog Number
502-189
Brand Name
HbA1c Calibrator Set
Version/Model Number
4 x 0.5mL
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)
Yes
FDA Premarket Submission
-
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
d37a8d9e-545d-49c6-9a6a-ad445cb6c3bc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |