Biomic V3
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00863504000217 | Date21 Mar 2023 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Biomic
- Generic Name
- Antimicrobial susceptibility/resistance testing interpretive software IVD
- Model / Ref / Catalog
- V3, BV3
- Primary DI / UDI-DI
- 00863504000217
- FDA Product Code
- KZK
- GMDN Term
- Antimicrobial susceptibility/resistance testing interpretive software IVD
- Device Class
- Class I
- Regulation Number
- 866.2850
- GUDID distribution status
- In Commercial Distribution
Other devices from Giles Scientific Inc
Properties
Other properties (12)
- Sterile: No
- Single Use: 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
- Lot / Batch Number: No
- Expiration Date: No