What is FDA product code LFG?

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

Clinical Chemistry › Toxicology Test SystemsRadioimmunoassay, Tricyclic Antidepressant Drugs

Profile-II ER®

Name: Profile-II ER®
Brand: Profile-II ER®

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates,…

Registry build 21.09.26

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (6), Guangdong (2), Beijing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LFG
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
Abon Biopharm (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	17
Prometheus Bio Inc.	Hangzhou	Zhejiang	Contract manufacturer	12
Hangzhou AllTest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Assure Tech. (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37
Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou	Guangdong	Complaint-file establishment	35
Co-Innovation Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	29

Record

Regulatory record for Profile-II ER®
Listed by	Medtox Diagnostics, Inc., United States
FDA product code	LFG
Device type	Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class	Class 2
Regulation	21 CFR 862.3910
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K002331
Record published	2023-06-01

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

Catalogue Numbers

Catalogue numbers for Profile-II ER®
Catalogue number	Size	Status
601684		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Healgen	Healgen Scientific Limited Liability Company	96
reditest®	Redwood Toxicology Laboratory, Inc.	49
iCup®	Instant Technologies, Inc.	33
Noble	Noble Medical Inc	21
Radioimmunoassay, Tricyclic Antidepressant Drugs	Alere San Diego, Inc.	19
MD DugScreen	Medical Disposables Corp	15
DTX®	ONE Step Detex Associates	14
accutest®	Jant Pharmacal Corp.	13
AlereTM iScreen®	Instant Technologies, Inc.	11
McKesson	Mckesson Medical-Surgical Inc.	7
Advin Multi-Drug Screen Test	Advin Biotech, Inc.	6
RealityCHECKTM	Wolfe & Associates Inc	5

Showing 12 of 85. All products under Radioimmunoassay, Tricyclic Antidepressant Drugs

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K011545	2001-06-08

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.