Identity
- Trade Name
- CIDEX™ OPA Solution Test Strips 60 Strips/Bottle EUDAMEDCidex FDA UDI
- Generic Name
- Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
- Device Name
- CIDEX™ OPA Solution Test Strips EUDAMEDCidex OPA Solution Test Strips FDA UDI
- Model / Reference
- 20392 EUDAMEDFDA UDI
- Description
- Cidex OPA Solution Test Strips FDA UDI
Identifiers
- Catalog Number
- 20392 FDA UDI
- Primary DI / UDI-DI
- 20705037045553 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A120000000000012L7 EUDAMED
- Unit of Use DI
- 80705037045555 EUDAMED
- 510(k) Number
- K081427 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- EMDN Code
- D99 DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
- GMDN Term
- Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ortho-phthalaldehyde (OPA) device disinfectant test strip
Cidex by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ortho-phthalaldehyde (OPA) device disinfectant test strip.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Metricide — METREX RESEARCH · Class II
- Serim® DISINTEK™ OPA Test Strips — SERIM RESEARCH CORP. · Class II
- AUTOSURE — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Cidex — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
Cleared under the same submission
K081427 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI 402e86a8-0361-4adf-87c2-d7357032ccf9 37 fields · synced Jul 28, 2026
- EUDAMED 706fdd9e-d356-4ef0-8501-8492320dc941 61 fields · synced Jul 28, 2026