What is FDA product code PUY?

The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates 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 notif

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

Amazewell

Name: Amazewell
Brand: Amazewell

Amazewell™ D-Pen™ Oral Fluid Drug Test, 4-Panel , 25T/Box

Registry build 21.09.26

11manufacturers in China registered for this device type

2catalogue 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 PUY
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
Weihai Kangzhou Biotechnology Engineering Co., Ltd.	Weihai	Shandong	Manufacturer	24
Hangzhou Lysun Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	22
Hangzhou Tongzhou Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	14

Record

Regulatory record for Amazewell
Listed by	Guangzhou Decheng Biotechnology Co., Ltd., China
FDA product code	PUY
Device type	Test, Barbiturate, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3150
Establishment	Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-09-27

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 Amazewell
Catalogue number	Size	Per pack	Status
DPO-744EUO		25	In distribution
DPO-12106EUO		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
T-Cube®	Instant Technologies, Inc.	2
UScreen®	Instant Technologies, Inc.	1

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.