Healgen

K243365 14 Panel Cup Type #22 with Clicker, Low Cutoff and 5AD: AMP500, BAR300, BUP10, BZO300, COC150, MET500, MDMA500, MOP300, MTD300, OXY100, PCP25, PPX300, TCA1000, THC50 + 5Adulterants…

Registry build 21.09.26

K243365 14 Panel Cup Type #22 with Clicker, Low Cutoff and 5AD: AMP500, BAR300, BUP10, BZO300, COC150, MET500, MDMA500, MOP300, MTD300, OXY100, PCP25, PPX300, TCA1000, THC50 + 5Adulterants (CR, NI, OX, pH, SG)

11manufacturers in China registered for this device type
56catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (2), 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 DJR
Manufacturer City Province Registered as Device types
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86
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
Hangzhou AllTest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
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
Hongkong Conlight Medical Group Limited Tai Kok Tsui Hong Kong Specification developer 11

Record

Regulatory record for Healgen
Listed by Healgen Scientific Limited Liability Company
FDA product code DJR
Device type Enzyme Immunoassay, Methadone
Device class Class 2
Regulation 21 CFR 862.3620
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 20, case of 4, case of 10, iner pack of 25

Catalogue Numbers

Catalogue numbers for Healgen
Catalogue number Size Status
HDOA-6125 In distribution
HCDOAEW-254 In distribution
HDOA-654 In distribution
HCDOAF-6125A3 In distribution
HDOA-154A3 In distribution
HDOA-385N In distribution
HDOA-1164 In distribution
HCDOAF-22105SA3 In distribution
HCDOAV-1145SA5 In distribution
HDOA-4104 In distribution
HCDOAV-6124 In distribution
HDOA-1864 In distribution
HCDOAV-5125 In distribution
HDOA-1105 In distribution
HDOA-395 In distribution
HCDOAV-164 In distribution
HCDOAV-10115A3 In distribution
HDOA-1145 In distribution
HDOA-2135 In distribution
HDOA-255 In distribution
DOAY-264 In distribution
HDOA-134 In distribution
HDOA-6125A3 In distribution
HDOA-3115 In distribution
HCDOAEW-6125 In distribution
HDOA-754 In distribution
HDOA-6114 In distribution
HDOA-1104C In distribution
HDOA-1454 In distribution
HDOA-344 In distribution
HDOA-1104 In distribution
HDOA-274 In distribution
HCDOAB-385T3AD In distribution
HDMA-114 In distribution
HDOA-10125 In distribution
HCDOAV-3104 In distribution
HDOA-6124A3 In distribution
HDOA-6125A3 In distribution
HDOA-254 In distribution
HCDOAF-274A6 In distribution
HDOA-264 In distribution
HDOA-675H In distribution
HDOA-1125 In distribution
HCDOAF-254A3 In distribution
HCDOAF-254 In distribution
HDOA-865 In distribution
HDOA-254K In distribution
HDOA-564 In distribution
HCDOAV-2145A3 In distribution
HDOA-144 In distribution
HDOA-465 In distribution
HDOA-5125 In distribution
HDOA-3124 In distribution
HDOA-354 In distribution
HDOA-8104 In distribution
HDOA-5064 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Identify Diagnostics Drug Test Cups Medical Distribution Group Inc 23
DOA 5 Panel Test Rapid Diagnostics, Inc. 20
Advin Multi-Drug Screen Test Advin Biotech, Inc. 14
ProScreen Instant Tech Subsidiary Acquisition 13
DrugCheck Express Diagnostics Int’l., Inc. 12
UCP Compact Drug Test Cups UCP Biosciences, Inc. 12
MD DugScreen Medical Disposables Corp 12
CLIAwaived Cliawaived,inc. 11
QuickTox Drug Screen Dipcard Branan Medical Corporation 10
U-Screen Instant Tech Subsidiary Acquisition 7
First Sign® Hemosure Inc. 7
Rtcii 2nd gen. American Bio Medica Corp. 7

Showing 12 of 170. All products under Enzyme Immunoassay, Methadone

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