Ace SA2011
Ace SA2011 is a Class II device made by Alfa Wassermann, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00857969006143), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857969006143 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00857969006143
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ace
- Generic name
- Total creatine kinase (CK) IVD, reagent
- Model / Ref / Catalog
- SA2011
- Primary DI / UDI-DI
- 00857969006143
- FDA product code
- CGS
- GMDN term
- Total creatine kinase (CK) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1215
- GUDID distribution status
- In Commercial Distribution
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