Alltest AMP500 Rapid Test Dipstick (Urine)

Alltest AMP500 Rapid Test Dipstick (Urine): 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Amphetamine, Over The Counter. 16 manufacturers in China are registered for this product code.

Registry build 21.09.26
16manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (8), Guangdong (4), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NFT
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
Co-Innovation Biotech Co., Ltd. Guangzhou Guangdong Contract manufacturer 29
Jcmed Tianjin Import AND Export Co., Ltd. Tianjin Tianjin Manufacturer 51
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
Eterbio, Inc. Zhuhai Guangdong Manufacturer 29
Safecare Biotech(Hangzhou)Co., Ltd. Huzhou Zhejiang Manufacturer 22
Vivachek Biotech (Hangzhou) Co., Ltd. Hangzhou, Zhuji Zhejiang Contract manufacturer 21

Showing 12 of 16. All 16 manufacturers in China registered for Test, Amphetamine, Over The Counter

Record

Regulatory record for Alltest AMP500 Rapid Test Dipstick (Urine)
Listed by Hangzhou AllTest Biotech Co., Ltd., China
FDA product code NFT
Device type Test, Amphetamine, Over The Counter
Device class Class 2
Regulation 21 CFR 862.3100
Establishment Contract manufacturer, Manufacturer
Record published 2026-04-21

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 Alltest AMP500 Rapid Test Dipstick (Urine)
Catalogue number Size Per pack Status
1 50 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Discover Plus American Screening, L.L.C. 59
Precision DX American Screening, L.L.C. 42
Discover American Screening, L.L.C. 32
iScreen™ Instant Technologies, Inc. 31
Reveal American Screening, L.L.C. 26
Prime Screen Wondfo USA Co., Ltd. 20
U-Catch Shenzhen Bioeasy Biotechnology Co., Ltd. 19
SAFElife™ Wondfo USA Co., Ltd. 18
DrugTect Multi-Drug Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd. 17
Precision Plus American Screening, L.L.C. 12
Rapid Response Btnx Inc. 11
OneScreen American Screening, L.L.C. 9

Showing 12 of 113. All products under Test, Amphetamine, Over The Counter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250727 2025-04-04
K244043 2025-02-27
K242540 2024-09-27
K241428 2024-06-17

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