FDA.reportPublic FDA data

SAS Legionella Controls

Primary DI
00780311000141
Brand
SAS Legionella Controls
Company
SA SCIENTIFIC, LTD.
Model
044413
Device description
SAS™ Legionella Controls are for use in monitoring the in vitro diagnostic performance of the SAS™ Legionella Test presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine; their performance has not been evaluated with other Legionella assays. These controls are for prescription use only.
Published
2018-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00780311000141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00780311000141007803110001417803110001410780311000141

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.

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