Duns Number:064608573
Device Description: RBC Folate - Atellica IM - CONS - 4 x 30mL
Catalog Number
10995440
Brand Name
Atellica™ IM RBC FOL
Version/Model Number
10995440
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
K172201,K172201
Product Code
CGN
Product Code Name
ACID, FOLIC, RADIOIMMUNOASSAY
Public Device Record Key
8b1fc077-1932-4543-91f3-638e25e7739c
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
June 05, 2018
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 |