Pointe Scientific, Inc. Microprotein Standard

Pointe Scientific, Inc. Microprotein Standard is intended for use as a microprotein standard for standardization or calibration of pyragallol red microprotein procedures. 1 x 15 ml.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code JGP
Manufacturer City Province Registered as Device types
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Record

Regulatory record for Pointe Scientific, Inc. Microprotein Standard
Listed by Horiba Instruments Incorporated, United States
FDA product code JGP
Device type Lowry (Colorimetric), Total Protein
Device class Class 2
Regulation 21 CFR 862.1635
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K070757
Record published 2016-08-31
Record revised 2025-10-02 (version 4)

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 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Pointe Scientific, Inc. Microprotein Standard
Catalogue number Size Status
P7582-STD In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 7
Vitros Ortho-Clinical Diagnostics, Inc. 3
ClearChem Diagnostics Inc. MicroProtein, Total Clearchem Diagnostics Inc. 1
JAS Diagnostics Drew Scientific, Ltd. 1

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