Who else makes this device?

Name: Serim® Disintek™ GTA 1.5% Test Strips
Brand: Serim® Disintek™ GTA 1.5% Test Strips

General Hospital › MiscellaneousSterilant, Medical Devices

Serim® Disintek™ GTA 1.5% Test Strips

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…

Registry build 21.09.26

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.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MED
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Serim® Disintek™ GTA 1.5% Test Strips
Listed by	Serim Research Corp., United States
FDA product code	MED
Device type	Sterilant, Medical Devices
Device class	Class 2
Regulation	21 CFR 880.6885
Establishment	Manufacturer, Exporter
Record published	2016-09-08
Record revised	2026-02-09 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C
Packaging	Kit of 2

Catalogue Numbers

Catalogue numbers for Serim® Disintek™ GTA 1.5% Test Strips
Catalogue number	Size	Per pack	Status
5136A		50	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sterilant, Medical Devices	Steris Corporation	149
Formed Irrigating Cystotomes	Sterimedix Ltd.	37
Hydrodissection Cannulae	Sterimedix Ltd.	29
Sterilant, Medical Devices	Corporation Steris Canada	29
Anterior Chamber Maintenance Cannulae	Sterimedix Ltd.	17
Anaesthetic Needles	Sterimedix Ltd.	14
Formed Capsularhexis Cystotomes	Sterimedix Ltd.	8
Refractive Cannulae	Sterimedix Ltd.	8
enspire	Corporation Steris Canada	8
Cidex™	Advanced Sterilization Products Services Inc.	8
Bimanual Cannulae and Hand Pieces	Sterimedix Ltd.	7
Bimanual I/A Systems	Sterimedix Ltd.	7

Showing 12 of 96. All products under Sterilant, Medical Devices

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K932047	1994-06-02
K913943	1992-03-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.