Icup®

15 catalogue numbers from I-DOA-167-1111, listed by Instant Technologies, Inc., under Enzyme Immunoassay, Cocaine And Cocaine Metabolites. 16 manufacturers in China are registered for this product code.

Registry build 21.09.26
16manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DIO
Manufacturer City Province Registered as Device types
Hangzhou Biotest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 41
Abon Biopharm (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Core Technology Co., Ltd. Changping District Beijing Contract manufacturer 14
Prometheus Bio Inc. Hangzhou Zhejiang Contract manufacturer 12
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86
Hangzhou AllTest Biotech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 48
Assure Tech. (Hangzhou) 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
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

Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Record

Regulatory record for iCup®
Listed by Instant Technologies, Inc.
FDA product code DIO
Device type Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device class Class 2
Regulation 21 CFR 862.3250
Record published 2017-05-08
Record revised 2022-06-10 (version 5)

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

Catalogue Numbers

Catalogue numbers for iCup®
Catalogue number Size Per pack Status
I-DOA-167-1111 25 In distribution
DUA-157-013 25 In distribution
DOA-137-031 25 In distribution
DUE-167-342 25 In distribution
I-DUE-177-491 25 In distribution
DOA-1107-331 25 In distribution
DUE-1107-291 25 In distribution
DOA-197-251 25 In distribution
I-DUE-187-071 25 In distribution
DUE-187-241 25 In distribution
DUE-197-261 25 In distribution
DOA-137-012 25 In distribution
I-DUE-197-261 25 In distribution
I-DUE-1117-101 25 In distribution
I-DOA-197-281 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 19
DrugCheck Express Diagnostics Int’l., Inc. 12
AlereTM iScreen® Instant Technologies, Inc. 9
MD DugScreen Medical Disposables Corp 9
Monitect Drug Screen Cassette Test Branan Medical Corporation 9
First Sign® Hemosure Inc. 8
Rapid Response Btnx Inc. 7
Identify® Diagnostics Drug Test Cards Medical Distribution Group Inc 7
iScreen™ Instant Technologies, Inc. 7
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup Alere San Diego, Inc. 7
DrugCheck Express Diagnostic Int’l, Inc. 7
Enzyme Immunoassay, Cocaine And Cocaine Metabolites W.h.p.m., Inc. 7

Showing 12 of 152. All products under Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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