FDA.reportPublic FDA data

Wampole ColorCard® Streptozyme®

Primary DI
10859035006221
Brand
Wampole ColorCard® Streptozyme®
Company
ALERE NORTH AMERICA, LLC
Model
46050
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
GTYAntigens, All Groups, Streptococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859035006221PrimaryGS10
00859035006224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085903500622110859035006221
00859035006224008590350062248590350062240859035006224

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
10859035006214Wampole ColorCard® ASO 470502018-09-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10612479281582McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
00810107290132Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290156Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
20810107290143Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290187Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
10722066010751Rapid ResponseBTNX IncGTY2025-05-29
00722066010754Rapid ResponseBTNX IncGTY2025-05-29
30888277191888MEDLINEMEDLINE INDUSTRIES, INC.GTY2023-12-18
10722066006846Rapid ResponseBTNX IncGTY2023-08-14
00722066006849Rapid ResponseBTNX IncGTY2023-08-14
00816862023725PreviewWONDFO USA CO., LTD.GTY2023-08-03
10816862023722PreviewWONDFO USA CO., LTD.GTY2023-08-03
00695684755256StrepAimGERMAINE LABORATORIES, INCGTY2023-01-17
06974849369120Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369137Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369144Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369151Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
20885380183628CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
10885380183621CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
00816862023589PreviewWONDFO USA CO., LTD.GTY2021-08-20
10816862023586PreviewWONDFO USA CO., LTD.GTY2021-08-20
05713106821756S. pneumoniae reference strain 1Ssi Diagnostica A/SGTY2021-08-01
05713106821763S. pneumoniae reference strain 2Ssi Diagnostica A/SGTY2021-08-01
05713106821770S. pneumoniae reference strain 3Ssi Diagnostica A/SGTY2021-08-01
05713106821787S. pneumoniae reference strain 4Ssi Diagnostica A/SGTY2021-08-01
05713106821794S. pneumoniae reference strain 5Ssi Diagnostica A/SGTY2021-08-01
05713106821800S. pneumoniae reference strain 6ASsi Diagnostica A/SGTY2021-08-01