Duns Number:045361136
Device Description: For use as a calibrator in the quantitative determination of human Hemoglobin A1c (HbA1c) For use as a calibrator in the quantitative determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay.
Catalog Number
0365-401
Brand Name
Direct Glycohemoglobin (HbA1c) Calibrator Set
Version/Model Number
0365-401
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
96b1a855-f957-4a7c-8880-98640259761a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |