N/A J32
by Hardy Diagnostics GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816576026777 | Date1 Jun 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- N/A
- Generic Name
- Multiple formulation agar culture medium IVD
- Model / Ref / Catalog
- J32
- Primary DI / UDI-DI
- 00816576026777
- FDA Product Code
- JSI, KZI
- GMDN Term
- Multiple formulation agar culture medium IVD
- Device Class
- Class I
- Regulation Number
- 866.2360, 866.2330
- Commercial Distribution
- In Commercial Distribution
Other devices from Hardy Diagnostics
Properties
Show properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No