Icassette™

iCassette DOA Multi-Dev(Urine) 25T

Registry build 21.09.26
10manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (4), Guangdong (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LAF
Manufacturer City Province Registered as Device types
Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Abon Biopharm (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
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
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
Nantong Egens Biotechnology Co., Ltd. Nantong Jiangsu Manufacturer 7

Record

Regulatory record for iCassette™
Listed by Instant Technologies, Inc.
FDA product code LAF
Device type Gas Chromatography, Methamphetamine
Device class Class 2
Regulation 21 CFR 862.3610
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 iCassette™
Catalogue number Size Per pack Status
DOA-1105-011 25 In distribution
DOA-195-011 25 In distribution
DOA-185-011 25 In distribution
DMD-102 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
iScreen™ Instant Technologies, Inc. 52
DrugCheck Express Diagnostics Int’l., Inc. 27
Gas Chromatography, Methamphetamine W.h.p.m., Inc. 25
iCup™ Instant Technologies, Inc. 19
MD DugScreen Medical Disposables Corp 18
DrugCheck Express Diagnostic Int’l, Inc. 9
Healgen Healgen Scientific Limited Liability Company 8
Statdip® Micro Distributing, L.C 8
ProScreen Instant Tech Subsidiary Acquisition 6
QuickProfile™ Drugs of Abuse Test Cup Lumiquick Diagnostics, Inc. 5
First Sign® Hemosure Inc. 5
Generic Chemtron Biotech, Inc. 5

Showing 12 of 76. All products under Gas Chromatography, Methamphetamine

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