FDA.reportPublic FDA data

reditest®

Primary DI
10858904006126
Brand
reditest®
Company
REDWOOD TOXICOLOGY LABORATORY, INC.
Model
011020002
Catalog number
DMA-114-OBC12B
Device description
PANEL 1 M-AMP
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858904006126PrimaryGS10
00858904006129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085890400612610858904006126
00858904006129008589040061298589040061290858904006129

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810173656764HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
10841824104737EZ CLICKW.H.P.M. INC.LAF2024-07-25
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LAF2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
B298305250DrugCheck Express Diagnostic Int'l, Inc.LAF2023-11-30
10833143000067iCup™Instant Technologies, Inc.LAF2023-09-12
10817763022609First SignW.H.P.M. INC.LAF2022-11-17
20869419000209Express ResultsTM Quest DiagnosticsLAF2022-03-28
10841824104843NAW.H.P.M. INC.LAF2021-10-12
10841824104812ECO II Cup ®W.H.P.M. INC.LAF2021-09-10
10817815020683CRL Stat Dip CardW.H.P.M. INC.LAF2021-08-25
10841824104805NAW.H.P.M. INC.LAF2021-08-25
10841824104782ECO II Cup ®W.H.P.M. INC.LAF2021-07-08
B2983057210DrugCheckExpress Diagnostic Int'l, Inc.LAF2021-06-18
10817405021304iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021311iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LAF2020-08-21
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10858886006480NOBLE NOBLE MEDICAL INCLAF2020-04-21
B2983044510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050110DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23