Home GUDID 00858022006018 First To Know Syphilis Test
Primary DI 00858022006018
Brand First To Know Syphilis Test
Company NOWDIAGNOSTICS, INC.
Model 8057-25-CP
Catalog number 8057-25-CP
Device description 25 count convenience pack
Published 2024-12-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00858022006018 Primary GS1 0 10858022006015 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00858022006018 00858022006018 858022006018 0858022006018 10858022006015 10858022006015
GMDN Terms# Term, Definition table Term Definition Treponema pallidum total antibody IVD, kit, rapid ICT, self-testing A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Treponema pallidum in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 079541513 Device count 25 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10858022006015 First To Know Syphilis Test 8057-25-CP 8057-25-CP 2024-12-09 00858022006001 First To Know Syphilis Test 8057-1 8057-1 2024-11-11 00858022006230 AdexusDx hCG Control Set (unassayed) 401.009 401.009 2023-02-14 00858022006193 AdexusDx hCG Test 8001-1 8001-1 2017-12-22 00858022006209 AdexusDx hCG Test 8001-25 8001-25 2017-12-22 00858022006216 AdexusDx hCG Test 8001-50 8001-50 2017-12-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10858022006015 First To Know Syphilis Test NOWDIAGNOSTICS, INC. SBZ 2024-12-09 00858022006001 First To Know Syphilis Test NOWDIAGNOSTICS, INC. SBZ 2024-11-11