Iscreen™

iScreen MTD Panel(Urine) 25T

Registry build 21.09.26
11manufacturers in China registered for this device type
1catalogue number

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 iScreen™
Listed by Instant Technologies, Inc.
FDA product code DJR
Device type Enzyme Immunoassay, Methadone
Device class Class 2
Regulation 21 CFR 862.3620
Record published 2023-02-07

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 30 °C
Packaging Master carton of 40

Catalogue Numbers

Catalogue numbers for iScreen™
Catalogue number Size Per pack Status
DMT-114 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Healgen Healgen Scientific Limited Liability Company 56
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

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