What is FDA product code PUX?

The amphetamine test is an in vitro diagnostic test for the qualitative analysis of amphetamine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notifi

Clinical Chemistry › Toxicology Test SystemsTest, Amphetamine, Employment And Insurance Testing, Exempt

DrugCheck

Name: DrugCheck
Brand: DrugCheck

DrugCheck SalivaScan Oral Fluid Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC

Registry build 21.09.26

11manufacturers in China registered for this device type

7catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PUX
Manufacturer	City	Province	Registered as	Device types
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
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
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
Hangzhou Lysun Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	22
Hangzhou Tongzhou Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	14
Xiamen Boson Biotech Co., Ltd.	Xiamen	Fujian	Manufacturer	6

Record

Regulatory record for DrugCheck
Listed by	Express Diagnostic Int’l, Inc.
FDA product code	PUX
Device type	Test, Amphetamine, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3100
Premarket notification	Exempt
Record published	2022-03-01
Record revised	2022-06-10 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for DrugCheck
Catalogue number	Size	Status
80628-EI		In distribution
80704-EI		In distribution
80913-EI		In distribution
80408-EI		In distribution
80502-EI		In distribution
80410-EI		In distribution
81006-EI		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
iSCREEN™	Instant Technologies, Inc.	17
Amazewell	Guangzhou Decheng Biotechnology Co., Ltd.	17
Prime Screen	Wondfo USA Co., Ltd.	10
Classic	Mlife Diagnostics LLC	9
Verify	Mlife Diagnostics LLC	5
Noble Dip Card with AD (Urine)	Noble Medical Inc	4
UScreen Oral	Guangzhou Decheng Biotechnology Co., Ltd.	3
T-Cube®	Instant Technologies, Inc.	3
Statswab®	Micro Distributing, L.C	3
Rapid Response 6 Panel Saliva Test Cup E/I Screening	Btnx Inc.	3
Origin Instant Oral Drug Test	Origin Diagnostics LLC	2
mLife Verify	Mlife Diagnostics LLC	2

Showing 12 of 28. All products under Test, Amphetamine, Employment And Insurance Testing, Exempt

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.