What is FDA product code PVH?

The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates 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 notification s

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

iSCREEN™

Name: iSCREEN™
Brand: iSCREEN™

9 Panel E&I OF Cube AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

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 PVH
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 iSCREEN™
Listed by	Instant Technologies, Inc.
FDA product code	PVH
Device type	Test, Opiates, Employment And Insurance Testing, Exempt
Device class	Class 2
Regulation	21 CFR 862.3650
Premarket notification	Exempt
Record published	2022-11-09

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 4 to 30 °C
Packaging	Master carton of 20

Catalogue Numbers

Catalogue numbers for iSCREEN™
Catalogue number	Size	Per pack	Status
ABTOFCUBE0901A		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Immunalysis	Immunalysis Corporation	8
Statswab®	Micro Distributing, L.C	5
Urine Dip Card	Instant Technologies, Inc.	2
Noble Drug Test Cup (Urine)	Noble Medical Inc	2
Amazewell	Guangzhou Decheng Biotechnology Co., Ltd.	1
Quest Diagnostics Oral Fluid Oxycodone Heia	Quest Diagnostics, Inc.	1
T-Cube®	Instant Technologies, Inc.	1
Noble Drug Test Cup with AD (Urine)	Noble Medical Inc	1
Statswabii®	Micro Distributing, L.C	1
co-innovation	Co-Innovation Biotech Co., Ltd.	1
DrugCheck	Express Diagnostic Int’l, 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.