Who else makes this device?

Name: Fastect II Drug Screen Dipstick Test
Brand: Fastect II Drug Screen Dipstick Test

Fastect II Drug Screen Dipstick Test · Enzyme Immunoassay, Cocaine and Cocaine Metabolites → Clinical Chemistry

16manufacturers in China registered for this device type

3catalogue numbers in this listing

5510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DIO
Manufacturer	City	Province	Registered as	Device types
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
Abon Biopharm (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	17
Core Technology Co., Ltd.	Changping District	Beijing	Contract manufacturer	14
Prometheus Bio Inc.	Hangzhou	Zhejiang	Contract manufacturer	12
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
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37
Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou	Guangdong	Complaint-file establishment	35
Changchun Wancheng BIO-Electron Co., Ltd.	Changchun	Jilin	Contract manufacturer	34
Co-Innovation Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	29

Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Record

Regulatory record for Fastect II Drug Screen Dipstick Test
Listed by	Branan Medical Corporation, United States
FDA product code	DIO
Device type	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device class	Class 2
Regulation	21 CFR 862.3250
510(k)	K022355
Record published	2016-08-01
Record revised	2022-06-10 (version 6)

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
Storage	Storage environment temperature 15 to 30 °C
Distribution end date	2020-12-04

Catalogue Numbers

Catalogue numbers for Fastect II Drug Screen Dipstick Test
Catalogue number	Size	Status
MF11		Withdrawn
BF10		Withdrawn
TF13		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Healgen	Healgen Scientific Limited Liability Company	19
iCup®	Instant Technologies, Inc.	15
DrugCheck	Express Diagnostics Int’l., Inc.	12
AlereTM iScreen®	Instant Technologies, Inc.	9
MD DugScreen	Medical Disposables Corp	9
Monitect Drug Screen Cassette Test	Branan Medical Corporation	9
First Sign®	Hemosure Inc.	8
Rapid Response	Btnx Inc.	7
Identify® Diagnostics Drug Test Cards	Medical Distribution Group Inc	7
iScreen™	Instant Technologies, Inc.	7
SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup	Alere San Diego, Inc.	7
DrugCheck	Express Diagnostic Int’l, Inc.	7

Showing 12 of 152. All products under Enzyme Immunoassay, Cocaine And Cocaine Metabolites

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K103227	2012-04-11
K032057	2003-08-21
K023489	2002-12-16
K022355	2002-07-30
K002264	2000-11-27

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Fastect II Drug Screen Dipstick Test
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Ameditech, Inc.	510(k) number	2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	108,000 units	2024-09-30
Ameditech, Inc.	510(k) number	2019-02-15	Class III	Labeling mix-ups	Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)	3400 units (136 kits)	2021-04-28

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-07-05	Class III	Labeling mix-ups	Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.	96 units	2016-10-04
2014-03-26	Class II	Labeling Change Control	May be labeled with incorrect result interpretation graphics on the ToxCup lid label.	9,800 units	2014-07-23

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.

Fastect II Drug Screen Dipstick Test