Identity
- Trade Name
- Serim® DISINTEK™ GTA 1.5% Test Strips FDA UDI
- Generic Name
- Glutaraldehyde device disinfectant/sterilant test strip FDA UDI
- Device Name
- Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants. FDA UDI
- Model / Reference
- 5136A FDA UDI
- Description
- Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants. FDA UDI
Identifiers
- Catalog Number
- 5136A FDA UDI
- Primary DI / UDI-DI
- M1745136A1 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Glutaraldehyde device disinfectant/sterilant test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 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: Glutaraldehyde device disinfectant/sterilant test strip
Serim® DISINTEK™ GTA 1.5% Test Strips by Serim Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glutaraldehyde device disinfectant/sterilant test strip.
- Metritest — METREX RESEARCH · Class II
- Wavicide MEC Indicator — Medical Chemical Corporation · Class II
- GlutarTest 1 — IBT Scientific · Class II
- Metritest — METREX RESEARCH · 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 f80c25b2-63c6-407a-ad56-478b47e43b6a 36 fields · synced Jun 8, 2026