Who else makes this device?

Name: CRL Stat ™
Brand: CRL Stat ™

Clinical Chemistry › Toxicology Test SystemsReagents, Test, Tetrahydrocannabinol

CRL Stat ™

DOA 5 in 1 Test CRL QuickScreen Cup W/AD, 25Pcs/Box; Without Security Label & No Disposable Gloves COC/mAMP/OPI/PCP/THC/PH-SG-OX CLIA waived

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 CRL Stat ™
Listed by	Clinical Reference Laboratory, Inc., United States
FDA product code	DKE
Device type	Reagents, Test, Tetrahydrocannabinol
Device class	Class 2
Regulation	21 CFR 862.3870
Establishment	Repacker / relabeller, Complaint-file establishment
Record published	2016-10-14
Record revised	2022-06-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for CRL Stat ™
Catalogue number	Size	Per pack	Status
KCUR920099		25	In distribution

Same Product Code

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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.