FDA.reportPublic FDA data

reditest®

Primary DI
10858904006089
Brand
reditest®
Company
REDWOOD TOXICOLOGY LABORATORY, INC.
Model
011020021
Catalog number
DPC-114-OBC12B
Device description
PANEL 1 PCP
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858904006089PrimaryGS10
00858904006082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085890400608910858904006089
00858904006082008589040060828589040060820858904006082

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
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
10858904006249reditest®011020015DOA-654-OBC12B2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLCM2019-02-13
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-04-19