What is FDA product code PVD?

The methamphetamine test is an in vitro diagnostic test for the qualitative analysis of methamphetamines 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 premark

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

Immunalysis

Name: Immunalysis
Brand: Immunalysis

SEFRIA Methamphetamine Oral Fluid is an enzyme immunoassay for qualitative and semi-quantitative analysis of methamphetamine in human oral fluid. It is designed for screening with clinical…

Registry build 21.09.26

SEFRIA Methamphetamine Oral Fluid is an enzyme immunoassay for qualitative and semi-quantitative analysis of methamphetamine in human oral fluid. It is designed for screening with clinical analyzers, and the assay reports a preliminary result for the named target.

The filed entry identifies the Immunalysis 611OF-0100 example. This is a target-specific oral-fluid assay, distinct from the company’s SEFRIA assays for other substances.

Listed Item

SEFRIA™ Methamphetamine Oral Fluid

Oral-Fluid Assay

The assay uses immunoassay reagents to measure methamphetamine in an oral-fluid specimen through an analyzer-based workflow. The result is preliminary and requires confirmation using a more specific method.

The product is the assay reagent system, not an oral-fluid collection device or a standalone analyzer.

13manufacturers in China registered for this device type

4catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PVD
Manufacturer	City	Province	Registered as	Device types
Hangzhou Rollmed Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	127
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

Showing 12 of 13. All 13 manufacturers in China registered for Test, Methamphetamine, Employment And Insurance Testing, Exempt

Record

Regulatory record for Immunalysis
Listed by	Immunalysis Corporation, United States
FDA product code	PVD
Device type	Test, Methamphetamine, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3610
Premarket notification	Exempt
Record published	2024-04-08
Record revised	2024-04-10 (version 5)

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
648OF-0100		In distribution
648OF-0500		In distribution
611OF-0100		In distribution
611OF-0500		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
T-Cube®	Instant Technologies, Inc.	3
Amazewell	Guangzhou Decheng Biotechnology Co., Ltd.	1
iScreen™	Instant Technologies, Inc.	1
Statswabii®	Micro Distributing, L.C	1
DrugCheck	Express Diagnostic Int’l, Inc.	1
HairCheck-DT Methamphetamine	Quest Diagnostics, 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.