What is FDA product code PVJ?

The cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids 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, Cannabinoid, Employment And Insurance Testing, Exempt

Iscreen™

Name: iScreen™
Brand: iScreen™

11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PVJ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
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 iScreen™
Listed by	Instant Technologies, Inc.
FDA product code	PVJ
Device type	Test, Cannabinoid, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3870
Premarket notification	Exempt
Record published	2023-12-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 36 to 86 °F
Packaging	Master carton of 4

Catalogue Numbers

Catalogue numbers for iScreen™
Catalogue number	Size	Per pack	Status
ABTOFCUBE1102B		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Verify	Mlife Diagnostics LLC	6
DrugCheck	Express Diagnostic Int’l, Inc.	6
Origin Instant Oral Drug Test	Origin Diagnostics LLC	4
Immunalysis	Immunalysis Corporation	2
T-Cube®	Instant Technologies, Inc.	2
Urine Dip Card	Instant Technologies, Inc.	1
MGC Health	Guangzhou Decheng Biotechnology Co., Ltd.	1
kangzhou	Weihai Kangzhou Biotechnology Engineering Co., Ltd.	1
UScreen®	Instant Technologies, Inc.	1
Origin Instant Drug Test	Origin Diagnostics LLC	1
HairCheck-DT (THC) Exempt	Quest Diagnostics, Inc.	1
Personal Care	Delta Brands Inc.	1

Showing 12 of 15. All products under Test, Cannabinoid, 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.