Identity
- Trade Name
- Actril Residual Test Strips FDA UDI
- Generic Name
- Medical device disinfection solution test strip FDA UDI
- Model / Reference
- 78258-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 40677964023987 FDA UDI
- 510(k) Number
- K861730 FDA UDI
- FDA Product Code
- FKQ FDA UDI
- GMDN Term
- Medical device disinfection solution test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
No
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
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: Medical device disinfection solution test strip
Actril Residual Test Strips by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K861730 also covers:
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
- Medivators Inc.
Sources (1)
- FDA UDI 0dc5ff56-d073-4b55-98fd-6a6869e28663 33 fields · synced May 30, 2026