Express ResultsTM

UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)

Registry build 21.09.26
10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (5), Guangdong (3), Jilin (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 JXN
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
Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Guangzhou Wondfo Biotech Co., Ltd. Guangzhou Guangdong Contract manufacturer 44
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 Express ResultsTM
Listed by Quest Diagnostics, Inc., United States
FDA product code JXN
Device type Enzyme Immunoassay, Propoxyphene
Device class Class 2
Regulation 21 CFR 862.3700
Record published 2022-03-28
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Express ResultsTM
Catalogue number Size Per pack Status
UDOA-12CE-0712-01 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Incup American Bio Medica Corp. 35
Rtcii 1st gen. American Bio Medica Corp. 23
Healgen Healgen Scientific Limited Liability Company 18
DrugSmart Cup Twin Spirit Inc. 6
ProScreen Instant Tech Subsidiary Acquisition 6
ToxCup Drug Screen Cup Branan Medical Corporation 5
McKesson Mckesson Medical-Surgical Inc. 4
DrugCheck Express Diagnostics Int’l., Inc. 4
Rtcii 2nd gen. American Bio Medica Corp. 4
RDS American Bio Medica Corp. 3
Profile-II ER® Medtox Diagnostics, Inc. 3
Syva® Emit® II Plus Propoxyphene Assay Siemens Healthcare Diagnostics Inc 3

Showing 12 of 69. All products under Enzyme Immunoassay, Propoxyphene

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