Beckmancoulter

CD34 Pool Kit - CD34 Pool-PE - Isotypic Control IgG(1+2a)-PE

Registry build 21.09.26
6manufacturers in China registered for this device type
678catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Hunan (1), Henan (1).

Chinese manufacturers registered for FDA product code MVU
Manufacturer City Province Registered as Device types
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22
Henan Celnovte Biotechnology Co., Ltd. Zhengzhou Henan Manufacturer 8
Phase Scientific (Shenzhen) Company Limited Shenzhen Guangdong Repacker / relabeller 8
Shenzhen Dartmon Biotechnology Co., Ltd. Shenzhen Guangdong Manufacturer 4
Shanghai ZJ BIO-Tech Co., Ltd. Shanghai Shanghai Private-label distributor 3
Diaglogic Biolabs (Xiamen) Co., Ltd. Xiamen Fujian Manufacturer 1

Record

Regulatory record for Beckmancoulter
Listed by Immunotech Corp., United States
FDA product code MVU
Device type Reagents, Specific, Analyte
Device class Class 1
Regulation 21 CFR 864.4020
Premarket notification Exempt
Record published 2020-03-05
Record revised 2020-03-10 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Beckmancoulter
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Showing 250 of 300 catalogue numbers.

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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