Helicobacter Pylori

10 catalogue numbers from ALA383G7, listed by Biocare Medical, LLC, United States, under Reagents, Specific, Analyte. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26
6manufacturers in China registered for this device type
10catalogue 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 Helicobacter pylori
Listed by Biocare Medical, LLC, United States
FDA product code MVU
Device type Reagents, Specific, Analyte
Device class Class 1
Regulation 21 CFR 864.4020
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-09-23

Specifications

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

Catalogue Numbers

Catalogue numbers for Helicobacter pylori
Catalogue number Size Status
ALA383G7 In distribution
CM383C In distribution
PM383H In distribution
PM383AA In distribution
OPAI383T60 In distribution
NPAA383T40 In distribution
PM383L In distribution
IP383G10 In distribution
NPAA383T80 In distribution
CM383A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CytoCell myProbes Cytocell Limited 1,286
Beckmancoulter Immunotech Corp. 678
CytoCell Cytocell Limited 587
MetaSystems Probes Metasystems Probes Gmbh 529
Reagents, Specific, Analyte Becton, Dickinson AND Company 288
Vysis Abbott Molecular, Inc. 248
Kreatech Fish probes Leica Biosystems Newcastle Ltd 197
Horizon Becton, Dickinson AND Company 145
goldFISH Lumatas Biosystems, Inc 119
Immunalysis Immunalysis Corporation 97
Invivoscribe Invivoscribe, Inc. 91
Fort Worth Diagnostics Fort Worth Diagnostics LLC 88

Showing 12 of 3,073. All products under Reagents, Specific, Analyte

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