Healgen

K243365 12 Panel Cup Type #31 with Low Cutoff and A3: AMP500, BAR300, BUP10, BZO300, COC150, MDMA500, MET500, MOP300, MTD300, OXY100, PCP25, THC50, +(OXI/SG/pH)

Registry build 21.09.26
9manufacturers in China registered for this device type
96catalogue 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 LFG
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
Co-Innovation Biotech Co., Ltd. Guangzhou Guangdong Contract manufacturer 29

Record

Regulatory record for Healgen
Listed by Healgen Scientific Limited Liability Company
FDA product code LFG
Device type Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class Class 2
Regulation 21 CFR 862.3910
Record published 2026-02-04
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 Storage environment temperature 2 to 30 °C
Packaging Inner pack of 25, case of 4, case of 20, inner pack of 100, case of 50, case of 100

Catalogue Numbers

Catalogue numbers for Healgen
Catalogue number Size Status
HDOA-254 In distribution
HCDOAV-454A3 In distribution
HDMD-101 In distribution
HDOA-1145 In distribution
HCDOAV-6125A3A In distribution
HCDOAV-164 In distribution
HCDOAEW-6125SA3 In distribution
HDOA-374 In distribution
HDED-114 In distribution
HCDOAEW-13104 In distribution
HDOP-201 In distribution
HCDOAEW-6125A3A In distribution
HCDOAV-5125A3A In distribution
HDOA-4105 In distribution
HCDOAV-154 In distribution
DOAY-5125 In distribution
HCDOA-8105A3 In distribution
HCDOAV-6125 In distribution
HDMD-114 In distribution
HDCO-101 In distribution
HDOA-574 In distribution
DOAY-6125A3 In distribution
HCDOAV-264A3 In distribution
HCDOAV-5125A3 In distribution
HCDOAV-4104 In distribution
HDBU-114 In distribution
HDOA-424 In distribution
HDOA-4964 In distribution
HCDOAV-1104S In distribution
HCDOAEC-6125A3 In distribution
HDMT-114 In distribution
HCDOAEW-8104 In distribution
DOAY-654 In distribution
DOAY-6125 In distribution
HDOA-6124 In distribution
HCDOAV-3124 In distribution
HCDOAV-275 In distribution
HCDOA-254 In distribution
HCDOAEW-264A3 In distribution
HDOA-535 In distribution
HCDOAEC-385 In distribution
HCDOAV-2145A3 In distribution
HCDOAEW-654 In distribution
HDOA-3104 In distribution
HCDOAV-254A3 In distribution
HDTC-114 In distribution
HDAM-114 In distribution
HDOA-164 In distribution
HCDOAV-855 In distribution
HDOA-865 In distribution
HDOA-184 In distribution
HCDOAV-265 In distribution
HCDOAV-7104 In distribution
HCDOAV-654A3 In distribution
HCDOAV-264 In distribution
HCDOAV-5125 In distribution
HCDOAV-6125A3 In distribution
HDPC-114 In distribution
HCDOAV-3104A3 In distribution
GBTHC-101a In distribution
HCDOAV-10115 In distribution
HCDOAEW-4105 In distribution
HDCO-114 In distribution
HCDOAV-564 In distribution
HCDOA-564 In distribution
HDOA-974N In distribution
HCDOAV-255 In distribution
DOAY-3124 In distribution
HDOX-201 In distribution
HCDOAV-3124 In distribution
HCDOAV-6124A3 In distribution
HCDOAV-254 In distribution
HCDOAV-274A3 In distribution
HDTH-101 In distribution
HCDOAEW-8105 In distribution
HCDOAV-10115S In distribution
HCDOAV-6125SA3A In distribution
HCDOA-5125 In distribution
HCDOAF-4104 In distribution
HCDOAV-4105 In distribution
HCDOA-955 In distribution
HDOA-1104C In distribution
HCDOAV-564 In distribution
HDOA-4104 In distribution
HCDOAV-3104 In distribution
HCDOAV-275S In distribution
HDOA-264 In distribution
HCDOAV-2135A3 In distribution
HCDOAV-654 In distribution
HCDOAV-6125SA3 In distribution
HCDOAV-334 In distribution
HDTC-114 In distribution
HDOA-7104 In distribution
HCDOAV-274 In distribution
HCDOAV-2145 In distribution
HCDOAV-1265 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
reditest® Redwood Toxicology Laboratory, Inc. 49
iCup® Instant Technologies, Inc. 33
Noble Noble Medical Inc 21
Radioimmunoassay, Tricyclic Antidepressant Drugs Alere San Diego, Inc. 19
MD DugScreen Medical Disposables Corp 15
DTX® ONE Step Detex Associates 14
accutest® Jant Pharmacal Corp. 13
AlereTM iScreen® Instant Technologies, Inc. 11
McKesson Mckesson Medical-Surgical Inc. 7
Advin Multi-Drug Screen Test Advin Biotech, Inc. 6
RealityCHECKTM Wolfe & Associates Inc 5
Express ResultsTM Quest Diagnostics, Inc. 5

Showing 12 of 85. All products under Radioimmunoassay, Tricyclic Antidepressant Drugs

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