FDA.reportPublic FDA data

N Latex ASL

Primary DI
00842768006807
Brand
N Latex ASL
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445984
Catalog number
OPBU05
Device description
Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Published
2020-09-24
Public version status
Update
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
00842768006807PrimaryGS10
00842768019241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006807008427680068078427680068070842768006807
00842768019241008427680192418427680192410842768019241

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)664-3822XX@XX.XX
+1(800)664-3822CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

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
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