Who else makes this device?

Name: Generic
Brand: Generic

Clinical Chemistry › Toxicology Test SystemsReagents, Test, Tetrahydrocannabinol

Generic

13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit

Registry build 21.09.26

1manufacturer

1catalogue number

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 Generic
Listed by	Chemtron Biotech, Inc., United States
FDA product code	DKE
Device type	Reagents, Test, Tetrahydrocannabinol
Device class	Class 2
Regulation	21 CFR 862.3870
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
510(k)	K142396
Record published	2018-10-26
Record revised	2022-06-10 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Generic
Catalogue number	Size	Status
712M06		In distribution

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

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.