RapiTex® ASL OUBA43

GUDID 00842768011108

Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum

Siemens Healthcare Diagnostics Products GmbH

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Primary Device ID00842768011108
NIH Device Record Key379226f7-aa37-49a9-92cb-320f152cdd34
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRapiTex® ASL
Version Model Number10446422
Catalog NumberOUBA43
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailXX@XX.XX
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)664-3822
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768011108 [Primary]

FDA Product Code

GTQANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-01-28
Device Publish Date2018-09-24

On-Brand Devices [RapiTex® ASL]

00842768012730Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human s
00842768011108Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human s
00842768011092Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human s

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