Identity
- Trade Name
- APIWEB™ FDA UDI
- Generic Name
- Human infectome analysis interpretive software IVD FDA UDI
- Device Name
- APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips. FDA UDI
- Model / Reference
- 1.4 FDA UDI
- Description
- APIWEB is a web based application for interpretation of biochemical/digital profiles for identification of microorganisms obtained from ID 32, rapid ID 32, and API strips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026133542 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Human infectome analysis interpretive software IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human infectome analysis interpretive software IVD
Apiweb™ by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human infectome analysis interpretive software IVD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 2a41adc5-92c1-48d8-ab07-18108d8517fd 33 fields · synced May 30, 2026