Home GUDID 10858022006015 First To Know Syphilis Test
Primary DI 10858022006015
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
Rx false
OTC true
Sterile false
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 DM exempt false Premarket exempt false 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 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00858022006018 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 00858022006018 First To Know Syphilis Test NOWDIAGNOSTICS, INC. SBZ 2024-12-09 00858022006001 First To Know Syphilis Test NOWDIAGNOSTICS, INC. SBZ 2024-11-11