Home GUDID 00840937103142 Immunalysis
Primary DI 00840937103142
Brand Immunalysis
Company IMMUNALYSIS CORPORATION
Model QS-76501
Catalog number QS-76501
Device description Quantisal Saliva Collection Device -100 Per Box, Specimen Bag - 100 Per Box
Published 2023-03-29
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 true Product Codes# Code, Name table Code Name PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840937113912 Primary GS1 0 00840937113929 Primary GS1 0 00840937113936 Primary GS1 0 00840937103142 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 00840937113912 00840937113912 840937113912 0840937113912 00840937113929 00840937113929 840937113929 0840937113929 00840937113936 00840937113936 840937113936 0840937113936 00840937103142 00840937103142 840937103142 0840937103142
GMDN Terms# Term, Definition table Term Definition Oral/upper respiratory tract specimen collection kit A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
Regulatory Flags# DUNS number 080589004 Device count 100 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840937113912 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937113929 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937113936 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937112052 Quantisal IMMUNALYSIS CORPORATION PJD 2020-10-06 00840937112069 Quantisal IMMUNALYSIS CORPORATION PJD 2020-10-06 00840937112144 Immunalysis IMMUNALYSIS CORP PJD 2020-08-31 00840937112151 Quantisal IMMUNALYSIS CORPORATION PJD 2020-08-31 00840937112168 Quantisal IMMUNALYSIS CORPORATION PJD 2020-08-31 00608337000115 OraSure Oral Fluid Collection Device Orasure Technologies, Inc. PJD 2019-02-15 20608337000119 OraSure Oral Fluid Collection Device Orasure Technologies, Inc. PJD 2019-02-15 10859952006236 Oral-Eze CAPITOL VIAL, INC. PJD 2018-08-31 30859952006261 Oral-Eze CAPITOL VIAL, INC. PJD 2018-08-31 00840937110812 Immunalysis IMMUNALYSIS CORP PJD 2018-04-20 00840937110829 Immunalysis IMMUNALYSIS CORP PJD 2018-04-20 10859952006045 Oral-Eze CAPITOL VIAL, INC. PJD 2018-01-12 00884883012639 Oral-Eze Sample Extractor Microgenics Corporation PJD 2017-12-20 00884883012646 Oral-Eze Sample Extractor Microgenics Corporation PJD 2017-12-20 00859952006093 Oral-Eze CAPITOL VIAL, INC. PJD 2017-07-25 00859952006109 Oral-Eze CAPITOL VIAL, INC. PJD 2017-07-25 00859952006055 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006062 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006079 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006086 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00884883012585 Oral-Eze Collection System Microgenics Corporation PJD 2016-09-12 00884883012653 Oral-Eze Collection System Microgenics Corporation PJD 2016-09-12 00859952006000 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006017 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006024 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006031 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00840937105078 Immunalysis IMMUNALYSIS CORP PJD 2016-08-31