Sure-Vue Pregnancy Strip

Primary DI
00780311000523
Brand
Sure-Vue Pregnancy Strip
Company
SA SCIENTIFIC, LTD.
Model
087525
Published
2018-11-02
Public version status
Update
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
00780311000523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00780311000523007803110005237803110005230780311000523

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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
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
00780311000066SAS ASO-Latex0811002018-11-02