Identity
- Trade Name
- AUTOSURE FDA UDI
- Generic Name
- Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
- Device Name
- MRC Reagent FDA UDI
- Model / Reference
- 23300 FDA UDI
- Description
- MRC Reagent FDA UDI
Identifiers
- Catalog Number
- 23300 FDA UDI
- Primary DI / UDI-DI
- 10705037048762 FDA UDI
- 510(k) Number
- K181472 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Ortho-phthalaldehyde (OPA) device disinfectant test strip
Autosure by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
- Cidex — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Cidex — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
Cleared under the same submission
K181472 also covers:
- ASP AERO-OPA — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
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
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI 850e4609-a1cb-450a-9a94-2f257f838ac1 37 fields · synced Jun 6, 2026