Duns Number:064608573
Device Description: Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL
Catalog Number
11099328
Brand Name
Atellica CH A1c_3 Calibrator
Version/Model Number
11099328
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2022
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
K081895,K081895
Product Code
JIX
Product Code Name
Calibrator, multi-analyte mixture
Public Device Record Key
ca070708-a5f2-4f69-bf7f-4f1527931420
Public Version Date
August 01, 2022
Public Version Number
7
DI Record Publish Date
December 22, 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 |