Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2000007960

FEI Number

2000007960

Entity Name

Derby supply chain solutions

City/State/Country

Cleveland, TN, US

Establishment Address

3285 Davy Crockett Dr., Cleveland, TN 37323, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Derby Industries, LLC (Owner Number: 10026511)

Owner / Operator Contact Address

3285 Davy Crockett Dr., Cleveland, TN 37323, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042272

PMA Number

N/A

All Registered Proprietary Names

Accutest Accutest Accutest Accutest

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2009-05-01
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-05-01
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-05-01
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-05-01
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-05-01
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-05-01
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2009-05-01
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2009-05-01
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2009-05-01

Official Correspondent

Shari Kepsel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Derby Industries, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110182	Guangzhou Wondfo Biotech Co., Ltd.	CANNABINOIDS URINE TEST	2011-05-20
K121557	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	2012-07-25
K920418	Instrumentation Laboratory CO	IL TEST CANNABINOID, 35282	1992-02-27
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2000007960. Last updated year: 2026. Please use registration number 2000007960 when referencing this establishment in official correspondence.