JAS Diagnostics XL-AMY2-30
JAS Diagnostics XL-AMY2-30 is a Class II device made by Drew Scientific, Ltd., listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274020845), 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 | Number00817274020845 | Date9 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817274020845
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- JAS Diagnostics
- Generic name
- Total amylase IVD, reagent
- Model / reference
- XL-AMY2-30
- Primary DI / UDI-DI
- 00817274020845
- FDA product code
- JFJ
- GMDN term
- Total amylase IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1070
- GUDID distribution status
- In Commercial Distribution
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