FDA.reportPublic FDA data

Wampole ColorCard® ASO

Primary DI
10859035006214
Brand
Wampole ColorCard® ASO
Company
ALERE NORTH AMERICA, LLC
Model
47050
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GTQAntistreptolysin - Titer/Streptolysin O Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTQAntistreptolysin - Titer/Streptolysin O ReagentMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859035006214PrimaryGS10
00859035006217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085903500621410859035006214
00859035006217008590350062178590350062170859035006217

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to extracellular antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-441-7440ts.scr@alere.com

Regulatory Flags#

DUNS number
826027364
Device count
50
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859035006023DENCOCCULT™ IIIL103E2016-09-24
10859035006016IMMUNEX CRP® 71S22016-09-24
10859035006238Acceava® Mono Cassette924072016-09-24
10859035006221Wampole ColorCard® Streptozyme® 460502018-09-24
10859035006009RHEUMATEX®34S22016-09-24
10859035006030IMPACT RPR™ TEST KIT (50 TESTS)60C1 2016-09-24
10859035006047IMPACT RPR™ TEST KIT (150 TESTS)60C22016-09-24
10859035006054IMPACT RPR™ TEST KIT (500 TESTS)60C32016-09-24
10859035006061IMPACT RPR™ TEST KIT (5000 TESTS)60C42016-09-24
10859035006078IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS)60C62016-09-24
10859035006085IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML61C02016-09-24
10859035006092IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML61C12016-09-24
10859035006108IMPACT RPR™ DRY CONTROL CARDS 10 EA61C22016-09-24
10859035006115IMPACT RPR™ LIQUID CONTROL 3 X 1 ML61C32016-09-24
10859035006122IMPACT RPR™ PIPETS/STIRRERS 500 EA61C42016-09-24
10859035006139IMPACT RPR™ 10 WELL TEST CARDS 300 EA61C52016-09-24
10859035006146IMPACT RPR™ 30 WELL TEST CARDS 100 EA61C72016-09-24
10859035006153IMPACT RPR™ NEEDLE/SHEATH 10 EA61C82016-09-24
10859035006160IMPACT RPR™ DISPENSING BOTTLES 10 EA61C92016-09-24
10859035006177IMPACT RPR™ PIPETS/STIRRERS 250 EA62C42016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336231432Tina-quant Antistreptolysin-O IIRoche Diagnostics GmbHGTQ2026-05-08
07613336231449Tina-quant Antistreptolysin-O IIRoche Diagnostics GmbHGTQ2026-05-08
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetTECO DIAGNOSTICSGTQ2026-05-07
10673486002447Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetTECO DIAGNOSTICSGTQ2024-04-02
00630414610856Atellica CH Anti-Streptolysin-O_3 (ASO_3)Siemens Healthcare Diagnostics Inc.GTQ2024-02-02
00630414305097Atellica CH Anti-Streptolysin-O_3 (ASO_3)Siemens Healthcare Diagnostics Inc.GTQ2024-02-02
06971674867067BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867074BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867081BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867104BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867111BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867128BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867135BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867838BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
00894175000619InstaTest™Diagnostic Automation, Inc.GTQ2021-12-13
04015630920860Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2021-01-18
04015630925711Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2021-01-18
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 ReagentsSiemens Healthcare Diagnostics Inc.GTQ2020-09-24
00630414596167Atellica CH ASO_2Siemens Healthcare Diagnostics Inc.GTQ2020-09-24
00842768006036Dimension Vista®Antistreptolysin O Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
00842768006791N Latex ASLSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
00842768006807N Latex ASLSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
10758750002306VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
10758750002726VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
10758750002733VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
07613336133545Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2020-03-05
00380740156251ARCHITECTABBOTT LABORATORIESGTQ2020-03-03
00380740156305ARCHITECTABBOTT LABORATORIESGTQ2020-03-03
05055273204292Anti-Streptolysin O (ASO)RANDOX LABORATORIES LIMITEDGTQ2019-06-03
05055273204315ANTI-STREPTOLYSIN-O 2 (ASO 2)RANDOX LABORATORIES LIMITEDGTQ2019-06-03