FDA.reportPublic FDA data

NA

Primary DI
00841824102088
Brand
NA
Company
W.H.P.M. INC.
Model
WBA-25
Catalog number
WBA-25
Device description
DOA Single Test Dipcard, 25Pcs/Box Clia Waived BARB
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102088PrimaryGS10
00841824100046Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102088008418241020888418241020880841824102088
00841824100046008418241000468418241000460841824100046

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate 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 barbiturates 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602085672
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841824105577ECOIIECOII-6664ECOII-66642026-03-19
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00811925030009ADS MedicalT1-CK30-ADSM2018-03-29
00811925030023ADS MedicalT1-CK30T-ADSM2018-03-29
00811925030030ADS MedicalT1-CK50-ADSM2018-03-29
00811925030047ADS MedicalT1-CT30-ADSM2018-03-29
00811925030054ADS MedicalT1-CT50-ADSM2018-03-29
00811925030061ADS MedicalT1-TB30-ADSM2018-03-29
00811925030078ADS MedicalT1-TB50-ADSM2018-03-29
00841824105706N/AW944W9442025-12-04
00841824105690EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105652N/AWMA500-25WMA500-252025-06-13
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105560ECOIIECOII-07144ECOII-071442024-08-22
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
10841824104737EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105416N/AW4374W43742024-06-14
00841824105409N/AW4374W43742024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDIS2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIS2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2019-02-12
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-12-05
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDIS2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDIS2018-05-21
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-03-14