FDA.report

Tina-quant Antistreptolysin O

Primary DI
07613336133545
Brand
Tina-quant Antistreptolysin O
Company
Roche Diagnostics GmbH
Model
08105472190
Catalog number
08105472190
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GTQANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT

Product Code Classifications

CodeDeviceSpecialtyClass
GTQAntistreptolysin - Titer/Streptolysin O ReagentMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336133545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336133545076133361335457613336133545

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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