Gamma-GT LiquiColor®

For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or Automated Procedures.

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code JQB
Manufacturer City Province Registered as Device types
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86

Record

Regulatory record for Gamma-GT LiquiColor®
Listed by Stanbio Laboratory, L.P.
FDA product code JQB
Device type Kinetic Method, Gamma-Glutamyl Transpeptidase
Device class Class 1
Regulation 21 CFR 862.1360
Premarket notification Exempt
Record published 2016-09-23
Record revised 2023-07-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Gamma-GT LiquiColor®
Catalogue number Size Status
2960-500 In distribution
2960-430 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Synermed® Infrared Laboratory Systems LLC 6
Pointe Scientific, Inc. Horiba Instruments Incorporated 5
JAS Diagnostics Drew Scientific, Ltd. 4
Gamma-Glutamyltransferase ver.2 Standardized against Ifcc / Szasz Roche Diagnostics Gmbh 4
Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240 Teco Diagnostics 3
GGT Assay Sekisui Diagnostics, LLC 2
Pointe Scientific, Inc. GGT Horiba Instruments Incorporated 2
AU Beckman Coulter, Inc. 2
Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) Teco Diagnostics 2
Pointe Scientific, Inc. GGT R1 Horiba Instruments Incorporated 1
Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2) Siemens Healthcare Diagnostics Inc 1
Piccolo General Chemistry 6 Abaxis, Inc. 1

Showing 12 of 27. All products under Kinetic Method, Gamma-Glutamyl Transpeptidase

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer