Identity
- Trade Name
- WOUNDCHEK™ Bacterial Status FDA UDI
- Generic Name
- Protease IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Intended for the assessment of bacterial protease activity in chronic wounds. FDA UDI
- Model / Reference
- 360006US FDA UDI
- Description
- Intended for the assessment of bacterial protease activity in chronic wounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011245 FDA UDI
- 510(k) Number
- DEN180014 FDA UDI
- FDA Product Code
- QFA FDA UDI
- GMDN Term
- Protease IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3231 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Protease IVD, kit, rapid ICT, clinical
WOUNDCHEK™ Bacterial Status by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 7b9cc812-387a-4954-b956-7cee754fe7da 34 fields · synced Jun 6, 2026