What is FDA product code PVA?

The cocaine and cocaine metabolite test is an in vitro diagnostic test for the qualitative analysis of cocaine and cocaine metabolites 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 i

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

Immunalysis

Name: Immunalysis
Brand: Immunalysis

SEFRIA™ Benzoylecgonine Oral Fluid

Registry build 21.09.26

12manufacturers 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 PVA
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
Xiamen Boson Biotech Co., Ltd.	Xiamen	Fujian	Manufacturer	6

Record

Regulatory record for Immunalysis
Listed by	Immunalysis Corporation, United States
FDA product code	PVA
Device type	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3250
Premarket notification	Exempt
Record published	2021-09-30
Record revised	2024-04-10 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Immunalysis
Catalogue number	Size	Status
612OF-0100		In distribution
612OF-0500		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
T-Cube®	Instant Technologies, Inc.	4
Statswabii®	Micro Distributing, L.C	3
eCUP + Drug Screening Device	Ameditech, Inc.	1
Amazewell	Guangzhou Decheng Biotechnology Co., Ltd.	1
MGC Health	Guangzhou Decheng Biotechnology Co., Ltd.	1
iCup®	Instant Technologies, Inc.	1
Statswab®	Micro Distributing, L.C	1
SAFElife™	Wondfo USA Co., Ltd.	1
mLife Classic	Mlife Diagnostics LLC	1
Prime Screen®	Wondfo USA Co., Ltd.	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.