Who else makes this device?

Name: Verdict®-II
Brand: Verdict®-II

Clinical Chemistry › Toxicology Test SystemsReagents, Test, Tetrahydrocannabinol

Verdict®-II

A qualitative one-step immunochromatographic test for the detection of Cannabinoids (THC) and/or metabolites in human urine.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code DKE
Manufacturer	City	Province	Registered as	Device types
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37

Record

Regulatory record for Verdict®-II
Listed by	Medtox Diagnostics, Inc., United States
FDA product code	DKE
Device type	Reagents, Test, Tetrahydrocannabinol
Device class	Class 2
Regulation	21 CFR 862.3870
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K003687
Record published	2016-09-16
Record revised	2022-11-28 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 25 °C
Packaging	Kit box of 25
Distribution end date	2021-04-30

Catalogue Numbers

Catalogue numbers for Verdict®-II
Catalogue number	Size	Status
601584		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Instant-View Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300	Alfa Scientific Designs, Inc.	54
Statcup®	Micro Distributing, L.C	20
First Sign®	Hemosure Inc.	12
Instant-View Multi-Drugs of Abuse Urine Test COC, MET1000, THC	Alfa Scientific Designs, Inc.	11
Statcup® II	Micro Distributing, L.C	9
Rtcii 2nd gen.	American Bio Medica Corp.	8
Statdip®	Micro Distributing, L.C	8
Instant-View Multi-Drugs of Abuse Dip Test AMP, BAR, BZD, COC, MET, MOR300 PCP,	Alfa Scientific Designs, Inc.	8
Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR MTD THC	Alfa Scientific Designs, Inc.	6
Instant-View Multi-Drugs of Abuse Urine Test BZD, COC, MOR300, MTD, THC	Alfa Scientific Designs, Inc.	5
Instant-View Multi-Drugs of Abuse Urine Test BAR, BZD, COC, MOR2000, OXY, THC	Alfa Scientific Designs, Inc.	4
Instant-View plus Multi-Drug Urine Test – Simple Cup (Prescription Use)	Alfa Scientific Designs, Inc.	3

Showing 12 of 38. All products under Reagents, Test, Tetrahydrocannabinol

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K003687	2000-12-22
K982211	1998-07-29

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.