Data / Medical devices / United States / American Screening Corporation

American Screening Corporation: FDA-registered device maker in Shreveport, LA, United States, 8 510(k) clearances

Name: American Screening Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

American Screening Corporation is registered with the FDA (registration 3006305917) in Shreveport, LA, United States. It lists 29 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 26, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006305917
Address: 9742 St. Vincent Street, Suite 100, Shreveport, LA, United States, 71106
Owner or operator: American Screening, LLC (10038017)
Roles: Repackager or relabeler
First device listed: December 23, 2020
Registered through: 2026
Brand names listed: Precision Dx, Reveal

Devices it lists

Device	Product code	Class	Role	Source
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Repackager or relabeler	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Repackager or relabeler	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Repackager or relabeler	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Repackager or relabeler	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Repackager or relabeler	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Repackager or relabeler	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Repackager or relabeler	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Repackager or relabeler	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Repackager or relabeler	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Repackager or relabeler	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 26, 2023	K233417	AllTest Fentanyl Urine Test Cassette	NGL	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
July 31, 2023	K231698	AllTest Fentanyl Rapid Test (Urine)	DJG	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
February 18, 2022	K212447	SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream	LCX	Substantially Equivalent	Hangzhou Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
January 31, 2022	K203272	Alltest Pregnancy Rapid Combo Test Cassette	JHI	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
March 27, 2019	K182738	Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)	DKZ	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
August 20, 2018	K181768	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	NFT	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
April 5, 2018	K180349	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	NFT	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
June 17, 2013	K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	DKZ	Substantially Equivalent	Advin Biotech	accessdata.fda.gov

Compare with other makers

Updated October 26, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.