Home GUDID 07613336228463 Elecsys Syphilis
Primary DI 07613336228463
Brand Elecsys Syphilis
Company Roche Diagnostics GmbH
Model 09015051162
Catalog number 09015051162
Published 2023-10-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MYR Test, donor, syphilis, antigens, treponemal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MYR Test, Donor, Syphilis, Antigens, Treponemal Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613336183083 Primary GS1 0 07613336228463 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613336183083 07613336183083 7613336183083 07613336228463 07613336228463 7613336228463
GMDN Terms# Term, Definition table Term Definition Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Regulatory Flags# DUNS number 315028860 Device count 20 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 07613336234457 PreciControl Syphilis 09465022190 09465022190 2026-05-15 04015630913893 AMYP Amylase EPS Pancreatic 20766623322 20766623322 2016-09-20 04015630910991 alpha-Amylase liquid acc. to IFCC 11876473316 11876473316 2016-09-20 04015630911004 Pancreatic alpha-amylase liquid 11876562316 11876562316 2016-09-20 04015630926848 alpha-Amylase EPS Pancreatic 5401771190 5401771190 2016-09-20 07613336121016 a-Amylase EPS Pancreatic 08056820190 08056820190 2020-03-05 07613336171509 Elecsys Calcitonin 09005676190 09005676190 2026-06-01 07613336171516 CalSet Calcitonin 09005684190 09005684190 2026-06-01 07613336188064 Elecsys Calcitonin 09005668160 09005668160 2026-06-01 07613336217641 Elecsys Anti-TSHR 09744819190 09744819190 2026-06-01 07613336218341 Elecsys CA 19-9 09755608190 09755608190 2026-06-01 07613336218389 Elecsys Estradiol III 09755659190 09755659190 2026-06-01 07613336235546 PreciControl HIV Gen II 09465006160 09465006160 2026-05-22 07613336231432 Tina-quant Antistreptolysin-O II 09537368190 09537368190 2026-05-08 07613336231449 Tina-quant Antistreptolysin-O II 09537341190 09537341190 2026-05-08 07613336154342 Elecsys Anti-HBc IgM 11820567160 11820567160 2017-09-29 07613336217832 Elecsys Testosterone II 09745963190 09745963190 2026-04-21 07613336153932 Elecsys Anti-HBc IgM 07026811160 07026811160 2018-03-19 00875197004748 cobas® HBV/HCV/HIV-1 Control Kit 1.0 06998887190 2015-12-04 07613336203606 Elecsys Anti-HBc II 09014918160 09014918160 2022-04-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613336183083 Elecsys Syphilis Roche Diagnostics GmbH MYR 2023-10-05 05060515140030 PK7400 TP HA REAGENT NEWMARKET BIOMEDICAL LIMITED MYR 2019-11-14 10888234001485 TPHA Screen IMMUCOR, INC. MYR 2016-04-15 10888234001492 TPHA Screen Diluent IMMUCOR, INC. MYR 2016-04-15 10888234001508 TPHA Screen Positive Control and TPHA Screen Negative Control IMMUCOR, INC. MYR 2016-04-15