Home GUDID 10190302016858 SpeciMAX Dx Saliva Collection Kit
Primary DI 10190302016858
Brand SpeciMAX Dx Saliva Collection Kit
Company LIFE TECHNOLOGIES CORPORATION
Model A51022
Device description SPECIMAX SALIVA KIT, IVD
Published 2022-04-13
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true Product Codes# Code, Name table Code Name KDT CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDT Container, Specimen Mailer And Storage, Sterile Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10190302016858 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10190302016858 10190302016858
GMDN Terms# Term, Definition table Term Definition Oral/respiratory tract specimen container IVD, no additive/medium An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 790376607 Device count 1 DM exempt true Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10190302018449 QuantStudio™ 7 Pro Dx Software, V3.0.0 A54626 2022-09-12 10190302018159 appliedbiosystems QuantStudioTM 7 Pro Dx Software A52649, V2.0.0 2022-05-02 10190302017862 QuantStudio™ 7 Pro Dx Software A52015, V1.0.5 2021-12-10 10190302002691 Dulbecco's Phosphate Buffered Saline (D-PBS) 14040141 2016-08-04 10190302000635 Dulbecco's Phosphate Buffered Saline (D-PBS) 14190136 2016-08-01 10190302002684 Hanks' Balanced Salt Solution (HBSS) 14025092 2016-08-04 10190302002721 Dulbecco's Phosphate Buffered Saline (D-PBS) 14040133 2016-08-04 10190302002837 Hanks' Balanced Salt Solution (HBSS) 14170112 2016-08-04 10190302002844 Hanks' Balanced Salt Solution (HBSS) 14175095 2016-08-04 10190302002875 Hanks' Balanced Salt Solution (HBSS) 14175079 2016-08-04 10190302003018 Dulbecco's Phosphate Buffered Saline (D-PBS) 14200075 2016-08-04 10190302003858 Hanks' Balanced Salt Solution (HBSS) 24020117 2016-08-04 10190302000628 Dulbecco's Phosphate Buffered Saline (D-PBS) 14040117 2016-08-01 10190302002950 Dulbecco's Phosphate Buffered Saline (D-PBS) 14190144 2016-08-01 10190302019439 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer A57740 2025-02-17 10190302018982 TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay A56440 2025-02-17 10190302018999 TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control 963612 2025-02-17 10190302019002 TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control 963609 2025-02-17 10190302019019 TaqPath™ 1-Step Select Master Mix (No ROX) A56518 A56123 2025-02-17 10190302019026 TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay A56441 2025-02-17
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