FDA.reportPublic FDA data

reditest®

Primary DI
10858904006300
Brand
reditest®
Company
REDWOOD TOXICOLOGY LABORATORY, INC.
Model
011020169
Catalog number
DOA-184-471
Device description
Panel 08 COC/ THC/AMP/MAMP/OPI2/MDMA/OXY/BZO
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
JXNEnzyme Immunoassay, Propoxyphene
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858904006300PrimaryGS10
00858904006303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085890400630010858904006300
00858904006303008589040063038589040063030858904006303

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-255-2159Qa.Portsmouth@abbott.com
1-877-444-0049Qa.Portsmouth@abbott.com

Regulatory Flags#

DUNS number
929599280
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10858904006010reditest®011020018DAM-114-OBC12B2016-09-24
10858904006027reditest®011020019DBA-114-OBC12B2016-09-24
10858904006034reditest®011020022DBZ-114-OBC12B2016-09-24
10858904006041reditest®011020001 DCO-114-OBC12B2016-09-24
10858904006058reditest®011020036DMD-114-OBC12B2016-09-24
10858904006065reditest®011020003 DMO-114-OBC12B2016-09-24
10858904006072reditest®011020020 DMT-114-OBC12B2016-09-24
10858904006089reditest®011020021 DPC-114-OBC12B2016-09-24
10858904006102reditest®011020004DTH-114-OBC12B2016-09-24
10858904006119reditest®011020037DOX-114-OBC12B2016-09-24
10858904006126reditest®011020002DMA-114-OBC12B2016-09-24
10858904006133reditest®011020030 DOA-824-OBC12B2016-09-24
10858904006140reditest®011020005 DOA-224-OBC12B2016-09-24
10858904006171reditest®011020006DOA-124-OBC12B2016-09-24
10858904006188reditest®011020011 DOA-334-OBC12B2016-09-24
10858904006195reditest®011020010 DOA-434-OBC12B2016-09-24
10858904006201reditest®011020009DOA-234-OBC12B2016-09-24
10858904006218reditest®011020014 DOA-534-OBC12B2016-09-24
10858904006225reditest®011020012 DOA-344-OBC12B2016-09-24
10858904006232reditest®011020032DOA-844-OBC12B2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03