Who else makes this device?

Name: Statcup® II
Brand: Statcup® II

Statcup® II · Reagents, Test, Tetrahydrocannabinol → Clinical Chemistry

1manufacturer

9catalogue numbers in this listing

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 Statcup® II
Listed by	Micro Distributing, L.C
FDA product code	DKE
Device type	Reagents, Test, Tetrahydrocannabinol
Device class	Class 2
Regulation	21 CFR 862.3870
510(k)	K133968
Record published	2019-01-17
Record revised	2024-10-14 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 4 to 30 °C

Catalogue Numbers

Catalogue numbers for Statcup® II
Catalogue number	Per pack	Status
STATⅡ-4267-A-CR	25	In distribution
STATⅡ-1257-0-A	25	In distribution
STATⅡ-1257	25	In distribution
STATⅡ-2387-A-CR	25	In distribution
STATⅡ-6167-A-CR	25	In distribution
STATII-6357	25	In distribution
STATⅡ-2167-3	25	In distribution
STATⅡ-2167-3-A	25	In distribution
STATⅡ-6257	25	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
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
Instant-View Marijuana (THC) Urine Dip Cassette Test	Alfa Scientific Designs, Inc.	3

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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Statcup® II
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Mckesson Medical-Surgical Inc. Corporate Office	510(k) number	2022-05-25	Class II	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.	a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k.

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.

Statcup® II