JAS Diagnostics GLU2-125
JAS Diagnostics GLU2-125 is a Class II device made by Drew Scientific, Ltd., cleared under FDA 510(k) K011900 on 31 Jul 2001 and listed in FDA GUDID since 6 Nov 2018 (UDI-DI 00817274022832), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817274022832 | Date6 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011900 | Date31 Jul 2001 | StatusActive |
Official records
- AccessGUDID record 00817274022832
- FDA 510(k) database K011900
Across registries
- FDA 510(k) K011900 decided 31 Jul 2001 Active
- FDA GUDID UDI-DI 00817274022832 listed 6 Nov 2018 Listed
Recalls
-
- Terminated Z-0827-2015
Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
-
- Terminated Z-1873-2014
JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
Timeline
- Cleared FDA 510(k) K011900
- Recall initiated FDA recalls Z-1873-2014
- Recall initiated FDA recalls Z-0827-2015
- Listed FDA GUDID 00817274022832
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- JAS Diagnostics
- Generic name
- Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
- Model / Ref / Catalog
- GLU2-125
- Description
- GLUCOSE HEXOKINASE (2 x 125mL)
- Primary DI / UDI-DI
- 00817274022832
- 510(k) Number
- FDA product code
- CGA
- GMDN term
- Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
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