ImmunoCard STAT! HpSA 750220
ImmunoCard STAT! HpSA 750220 is a Class I device made by Meridian Bioscience Inc., listed in FDA GUDID since 6 Aug 2018 (UDI-DI 00840733101380), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840733101380 | Date6 Aug 2018 | StatusListed |
Official records
- AccessGUDID record 00840733101380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ImmunoCard STAT! HpSA
- Generic name
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- 750220
- Primary DI / UDI-DI
- 00840733101380
- FDA product code
- LYR
- GMDN term
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3110
- GUDID distribution status
- In Commercial Distribution
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