Duns Number:064608573
Device Description: HCG total Diluent (6PK) - CENTAUR - CAL - 6x25mL
Catalog Number
117157
Brand Name
ADVIA Centaur® ThCG Diluent
Version/Model Number
10323214
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
K925277,K925277
Product Code
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
0007df96-641a-45ba-ab33-1a6ffcfb479d
Public Version Date
December 10, 2021
Public Version Number
6
DI Record Publish Date
September 24, 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 | 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 |