Identity
- Trade Name
- Serim® DISINTEK™ OPA Test Strips FDA UDI
- Generic Name
- Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
- Device Name
- Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%. FDA UDI
- Model / Reference
- 5121 FDA UDI
- Description
- Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%. FDA UDI
Identifiers
- Catalog Number
- 5121 FDA UDI
- Primary DI / UDI-DI
- M17451211 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- GMDN Term
- Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
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: Ortho-phthalaldehyde (OPA) device disinfectant test strip
Serim® DISINTEK™ OPA Test Strips by Serim Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ortho-phthalaldehyde (OPA) device disinfectant test strip.
- AUTOSURE — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Metricide — METREX RESEARCH · Class II
- Cidex — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Cidex — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Serim Research Corp.
Sources (1)
- FDA UDI c260f68e-2a71-4829-a04e-576ebb1abeaf 36 fields · synced May 30, 2026