Identity
- Trade Name
- Tristel Test Strips FDA UDI
- Generic Name
- Medical device disinfection solution test strip FDA UDI
- Device Name
- The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC). A vial/bottle of 50 test strips. Stopwatch. Polyethylene container. 10ml measure syringe. User Guide. FDA UDI
- Model / Reference
- 45-13 FDA UDI
- Description
- The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC). A vial/bottle of 50 test strips. Stopwatch. Polyethylene container. 10ml measure syringe. User Guide. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060171914686 FDA UDI
- 510(k) Number
- DEN220041 FDA UDI
- FDA Product Code
- QWS FDA UDI
- GMDN Term
- Medical device disinfection solution test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6886 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
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
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
Tristel Test Strips by Tristel Solutions Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection solution test strip.
- Minncare HD Residual Test Strips — MEDIVATORS INC. · Class II
- Revital-Ox Resert — Albert Browne , Ltd. · Class II
- QwikCheck® — CS MEDICAL LLC · Class II
- Celerity — Albert Browne , Ltd. · Class II
- Actril Residual Test Strips — MEDIVATORS INC. · Class II
- VERIFY — Albert Browne , Ltd. · Class II
- Serim® GUARDIAN™ Peracetic Acid Test Strips — SERIM RESEARCH CORP. · Class II
- Rapicide Glutaraldehyde Indicator Test Strips — MEDIVATORS INC. · Class II
Cleared under the same submission
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
- Tristel Solutions Limited
Sources (1)
- FDA UDI 79e898b4-1853-4904-8510-91740b95794b 34 fields · synced May 30, 2026