FDA.reportPublic FDA data

Atellica CH Anti-Streptolysin-O_3 (ASO_3)

Primary DI
00630414610856
Brand
Atellica CH Anti-Streptolysin-O_3 (ASO_3)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537212
Catalog number
11537212
Device description
Antistreptolysin O (ASO_3) Atellica CH
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00630414610856PrimaryGS10
00630414305097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414610856006304146108566304146108560630414610856
00630414305097006304143050976304143050970630414305097

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials 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, using a nephelometry/turbidimetry method.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

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
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
05055273204322ANTI-STREPTOLYSIN-O 2 (ASO 2)RANDOX LABORATORIES LIMITEDGTQ2019-06-03