Duns Number:064608573
Device Description: HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Catalog Number
10995445
Brand Name
Atellica IM aHAVM QC
Version/Model Number
10995445
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)
-
FDA Premarket Submission
P040018
Product Code
LOL
Product Code Name
Hepatitis a test (antibody and igm antibody)
Public Device Record Key
7f45bc5c-bfee-4cc1-81ab-6c2f3c66412e
Public Version Date
February 16, 2022
Public Version Number
6
DI Record Publish Date
December 27, 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 |