FDA.reportPublic FDA data

Rheumajet ASO 100 TESTS

Primary DI
08426950457305
Brand
Rheumajet ASO 100 TESTS
Company
BIOKIT, S.A.
Model
3000-7010
Device description
2 x 2.5 ml REAGENT1 x 1.5 ml CONTROL +1 x 1.5 ml CONTROL –2 x 9 SLIDES
Published
2016-09-23
Public version status
Update
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
08426950457305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950457305084269504573058426950457305

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-800-926-3353support@inovadx.com

Regulatory Flags#

DUNS number
460055742
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08426950639725BIO-FLASH3710-03442016-09-23
08426950344773Color Mono 50 TESTS3000-10052016-09-23
08426950590453ASO Titer Control3000210602016-09-23
08426950590477RF Titer Control3000210622016-09-23
08426950590569Rubagen 100 TESTS3000240012016-09-23
08426950590576Rubajet 100 TESTS3000240112016-09-23
08426950590583Rubajet 500 TESTS3000240122016-09-23
08426950589365Rheumajet CRP 100 TESTS3000-70512016-09-23
08426950590460CRP Titer Control3000210612016-09-23
08426951056439biokitHSV-23000280012022-10-10
08426950001676Monogen 50 TESTS3000-10012016-09-23
08426950585350Monogen 150 TESTS3000-10022016-09-23
08426950589334Rheumajet RF 100 TESTS3000-70332016-09-23
08426950590613Rheumajet RF 50 TESTS3000270342016-09-23
08426950592327Biokit RPR 500 TESTS3006255502016-09-23

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