Healgen

K240686 10 Panel DOA Test Dip Card with 3AD: AMP1000, BAR300, BZO300, COC300, MET1000, MTD300, OPI2000, PCP25, TCA1000, THC50 WITH 3 adulterate OX/SG/PH

Registry build 21.09.26
13manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JXM
Manufacturer City Province Registered as Device types
Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Hangzhou Biotest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 41
Abon Biopharm (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Prometheus Bio Inc. Hangzhou Zhejiang Contract manufacturer 12
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86
Hangzhou AllTest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Guangzhou Wondfo Biotech Co., Ltd. Guangzhou Guangdong Contract manufacturer 44
W.h.p.m. Bioresearch & Technology Co., Ltd. Beijing Beijing Manufacturer 37
Guangzhou Decheng Biotechnology Co., Ltd. Guangzhou Guangdong Complaint-file establishment 35
Changchun Wancheng BIO-Electron Co., Ltd. Changchun Jilin Contract manufacturer 34
Co-Innovation Biotech Co., Ltd. Guangzhou Guangdong Contract manufacturer 29
Hangzhou Clongene Biotech Co., Ltd. Hangzhou Zhejiang Manufacturer 21

Showing 12 of 13. All 13 manufacturers in China registered for Enzyme Immunoassay, Benzodiazepine

Record

Regulatory record for Healgen
Listed by Healgen Scientific Limited Liability Company
FDA product code JXM
Device type Enzyme Immunoassay, Benzodiazepine
Device class Class 2
Regulation 21 CFR 862.3170
Record published 2025-12-19
Record revised 2022-06-10 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Handling environment temperature 2 to 30 °C
Packaging Inner pack of 25, case of 4, case of 20

Catalogue Numbers

Catalogue numbers for Healgen
Catalogue number Size Status
HDOA-285 In distribution
HCDOAV-274 In distribution
HDOA-654 In distribution
HCDOAV-8104 In distribution
HDOA-1144 In distribution
HCDOAV-6125 In distribution
HCDOAV-274A3 In distribution
HCDOAV-254 In distribution
HDOA-1104A3 In distribution
HCDOAV-975 In distribution
HCDOAV-264 In distribution
HDCO-114 In distribution
HCDOA-855 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MD DugScreen Medical Disposables Corp 27
First Sign® Hemosure Inc. 26
MD DrugScreen Medical Disposables Corp 20
DrugCheck Express Diagnostics Int’l., Inc. 17
Statdip® Micro Distributing, L.C 17
Statcup® II Micro Distributing, L.C 16
DrugCheck Express Diagnostic Int’l, Inc. 15
QuickProfile™ Drugs of Abuse Test Cup Lumiquick Diagnostics, Inc. 11
ECO™ Cup W.h.p.m., Inc. 8
ECO™ II Cup W.h.p.m., Inc. 8
U-Screen Instant Tech Subsidiary Acquisition 7
Identify ®Diagnostics Drug Test Cups Medical Distribution Group Inc 6

Showing 12 of 145. All products under Enzyme Immunoassay, Benzodiazepine

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