Who else makes this device?

Name: QuanTtest Red Pyrogallol Red Reagent
Brand: QuanTtest Red Pyrogallol Red Reagent

Clinical Chemistry › Test SystemsBiuret (Colorimetric), Total Protein

QuanTtest Red Pyrogallol Red Reagent

QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in…

Registry build 21.09.26

QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.

3manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (1), Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CEK
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for QuanTtest Red Pyrogallol Red Reagent
Listed by	Quantimetrix Corp., United States
FDA product code	CEK
Device type	Biuret (Colorimetric), Total Protein
Device class	Class 2
Regulation	21 CFR 862.1635
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K904603
Record published	2017-06-30
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C; Handling environment temperature 18 to 25 °C

Catalogue Numbers

Catalogue numbers for QuanTtest Red Pyrogallol Red Reagent
Catalogue number	Size	Status
5210-12		In distribution
5210-12		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	17
Synermed®	Infrared Laboratory Systems LLC	10
JAS Diagnostics	Drew Scientific, Ltd.	6
Pointe Scientific, Inc.	Horiba Instruments Incorporated	5
AU	Beckman Coulter, Inc.	5
Pointe Scientific, Inc. Total Protein	Horiba Instruments Incorporated	5
Synchron	Beckman Coulter, Inc.	3
Total Protein 2 (TP 2)	Randox Laboratories Limited	3
Total Protein	Roche Diagnostics Gmbh	3
Alinity	Abbott Ireland	2
Pointe Total Protein Reagent	Horiba Instruments Incorporated	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2

Showing 12 of 61. All products under Biuret (Colorimetric), Total Protein

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K853932	1985-12-19
K853930	1985-12-10

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.