Home GUDID 00840937113929 Immunalysis
Primary DI 00840937113929
Brand Immunalysis
Company IMMUNALYSIS CORP
Model QS-0100
Catalog number QS-0010
Device description Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator
Published 2023-03-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00840937113929 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840937113929 00840937113929 840937113929 0840937113929
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 002804244 Device count 1 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 00840937113912 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937113936 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937103142 Immunalysis IMMUNALYSIS CORPORATION 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