FDA.reportPublic FDA data

CliaWaived Rapid Strep A Test

Primary DI
00780311000882
Brand
CliaWaived Rapid Strep A Test
Company
SA SCIENTIFIC, LTD.
Model
ST-501
Published
2019-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00780311000882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00780311000882007803110008827803110008820780311000882

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Streptococcus pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122092117
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00780311000011SAS Pregnancy Serum/Urine087730-N2018-11-01
00780311000103SAS hCG Serum Control Set0877122018-11-01
00780311000196SAS One-Step Pregnancy0874302018-11-02
00780311000202SAS One-Step Pregnancy0875002018-11-01
00780311000226SAS Pregnancy Serum/Urine087750-N2018-11-01
00780311000233SAS Pregnancy Strip0875252018-11-02
00780311000240SAS Pregnancy Ultimate0877312018-11-02
00780311000257SAS Pregnancy Ultimate0877512018-11-02
00780311000264SAS Pregnancy Urine087430-N2018-11-02
00780311000400SAS Serum/Urine hCG087701-S2018-11-02
00780311000417SAS Serum/Urine hCG0877302018-11-02
00780311000424SAS Serum/Urine hCG0877502018-11-01
00780311000455SAS Ultimate hCG Serum Contol Set0877152018-11-01
00780311000462SAS Ultimate hCG0877312018-11-01
00780311000479SAS Ultimate hCG0877512018-11-01
00780311000486SAS hCG Urine Control Set0874132018-11-01
00780311000523Sure-Vue Pregnancy Strip0875252018-11-02
00780311000592Sure-Vue hCG Serum Control Set0877122018-11-02
00780311000608Sure-Vue hCG-STAT Serum Control Set0877152018-11-02
00780311000615Sure-Vue hCG Urine Control set0874132018-11-02