Alpha-Tec Systems

PRO-Clear 1L

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code KEM
Manufacturer City Province Registered as Device types
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31

Record

Regulatory record for Alpha-Tec Systems
Listed by Alpha-Tec Systems, Inc., United States
FDA product code KEM
Device type Agent, Clearing
Device class Class 1
Regulation 21 CFR 864.4010
Premarket notification Exempt
Record published 2022-08-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Alpha-Tec Systems
Catalogue number Size Status
0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 17
Agent, Clearing Scientific Device Laboratory, Inc. 6
Fisherbrand Fisher Scientific Company L.L.C. 5
Remel Remel, Inc. 1
EliA Stool Extraction Buffer plus Phadia AB 1
Clear Aid Helena Laboratories, Corp. 1
PermaClear Clearing Solution Helena Laboratories, Corp. 1
Cardinal Health Cardinal Health 200, LLC 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