FDA.report

Antistreptolysin O AMR Fluid

Primary DI
05051700016438
Brand
Antistreptolysin O AMR Fluid
Company
THE BINDING SITE GROUP LIMITED
Model
BP529
Published
2023-06-07
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
false

Related Records

Contact Domains

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051700016438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051700016438050517000164385051700016438

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

Contacts

PhoneEmail
+441214569500info@bindingsite.co.uk

Regulatory Flags

DUNS number
347045614
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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