Home GUDID 15420045507210 Aptima®
Primary DI 15420045507210
Brand Aptima®
Company Hologic, Inc.
Model KIT, BOX 1, REFRIG, AHSV, 100T, IVD
Catalog number ASY-08088
Device description Aptima® HSV 1 & 2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Published 2017-06-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OQO Herpes simplex virus nucleic acid amplification assay
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OQO Herpes Simplex Virus Nucleic Acid Amplification Assay Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15420045507210 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15420045507210 15420045507210
GMDN Terms# Term, Definition table Term Definition Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 050579217 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08885013953664 Sentosa SA201 HSV-1/2 PCR Test VELA OPERATIONS SINGAPORE PTE. LTD. OQO 2018-04-16 25420045510187 Aptima® Hologic, Inc. OQO 2018-01-16 15420045507227 Aptima® Hologic, Inc. OQO 2017-06-23 15420045507234 Aptima® Hologic, Inc. OQO 2017-06-23 25420045507248 Aptima® Hologic, Inc. OQO 2017-02-16 04053228004660 artus® HSV-1/2 QS-RGQ MDx Kit QIAGEN GmbH OQO 2017-01-04 00875197004434 cobas® 4800 System Lysis Kit Roche Molecular Systems, Inc. OQO 2016-09-24 00875197004458 cobas® 4800 Systems Internal Control Kit Roche Molecular Systems, Inc. OQO 2016-09-24 00875197005264 cobas® 4800 System Lysis Kit Roche Molecular Systems, Inc. OQO 2016-09-24 20816101025507 Simplexa™ HSV 1 & 2 Direct DIASORIN MOLECULAR LLC OQO 2016-09-22 20816101025514 Simplexa™ HSV 1 & 2 Positive Control Pack DIASORIN MOLECULAR LLC OQO 2016-09-22 30014613312109 AmpliVue QUIDEL CORPORATION OQO 2016-09-15 00840487101032 Mutlicode®-RTx HSV 1&2 Kit LUMINEX CORPORATION OQO 2016-09-09 00382904417482 Control Set for the BD ProbeTec™ Herpes Simplex Viruses BECTON, DICKINSON AND COMPANY OQO 2016-07-07 00382904417499 BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack BECTON, DICKINSON AND COMPANY OQO 2016-07-07
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