Synermed®

GGT Reagent 6 X 500 mL (reconstituted)

Registry build 21.09.26
1manufacturer
6catalogue 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 Synermed®
Listed by Infrared Laboratory Systems LLC
FDA product code JQB
Device type Kinetic Method, Gamma-Glutamyl Transpeptidase
Device class Class 1
Regulation 21 CFR 862.1360
510(k) K931958
Record published 2016-09-20
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 0 to 4 °C

Catalogue Numbers

Catalogue numbers for Synermed®
Catalogue number Size Status
VI410-WK In distribution
VI410-X In distribution
VI410-1200 In distribution
VI411-L In distribution
VI410-R In distribution
VI410-911 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Gamma-GT LiquiColor® Stanbio Laboratory, L.P. 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