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

First Check(R)

Name: First Check(R)
Brand: First Check(R)

First Check(R) Home Drug Test, 14 Drug

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

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 First Check(R)
Listed by	First Check Diagnostic Corp.
FDA product code	LFG
Device type	Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class	Class 2
Regulation	21 CFR 862.3910
510(k)	K122633
Record published	2018-04-11
Record revised	2022-06-10 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F
Distribution end date	2021-03-31

Catalogue Numbers

Catalogue numbers for First Check(R)
Catalogue number	Size	Status
14 Drug Test		Withdrawn

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

Recalls Naming This Product

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

Recalls naming the identifiers of First Check(R)
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.	28,525	2024-09-30
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.	120, 150	2024-09-30
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.	31,600 units	2024-09-30
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.	31,800 units	2024-09-30
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.	13,700 units	2024-09-30
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.	136,925 units	2024-09-30
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.	189,175 units	2024-09-30
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.	47,005 units	2024-09-30

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.