Quantisal

Primary DI
00840937112052
Brand
Quantisal
Company
IMMUNALYSIS CORPORATION
Model
QSI-POUCH
Catalog number
QSI-POUCH
Device description
Quantisal I (25/100) Test
Published
2020-10-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection DeviceClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937112052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937112052008409371120528409371120520840937112052

GMDN Terms#

Term, Definition table
TermDefinition
Oral specimen collection kit, transport mediumA collection of non-sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the mouth, for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], sometimes sterile, and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-482-0840info@immunalysis.com

Regulatory Flags#

DUNS number
080589004
Device count
1
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 DIBrandModelCatalogPublished
00840937112151QuantisalQSI-0025QSI-00252020-08-31
00840937112168QuantisalQSI-0500QSI-05002020-08-31
00840937105986Immunalysis CorporationCP-2372016-08-31
00840937106006Immunalysis CorporationCP-2392016-08-31
00840937106020Immunalysis CorporationCP-2422016-08-31
00840937106266Immunalysis CorporationFC-206-602016-08-31
00840937106280Immunalysis CorporationFC-207-152016-08-31
00840937106297Immunalysis CorporationFC-207-252016-08-31
00840937106303Immunalysis CorporationFC-207-602016-08-31
00840937106310Immunalysis CorporationFC-207-7502016-08-31
00840937106334Immunalysis CorporationFC-207B-602016-08-31
00840937106341Immunalysis CorporationFC-207B-7502016-08-31
00840937106358Immunalysis CorporationFC-208-252016-08-31
00840937106365Immunalysis CorporationFC-208-602016-08-31
00840937106372Immunalysis CorporationFC-208-7502016-08-31
00840937106389Immunalysis CorporationFC-209-252016-08-31
00840937106396Immunalysis CorporationFC-209-602016-08-31
00840937106402Immunalysis CorporationFC-209-7502016-08-31
00840937106419Immunalysis CorporationFC-210-252016-08-31
00840937106426Immunalysis CorporationFC-210-602016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840937113912ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
00840937113929ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
00840937113936ImmunalysisIMMUNALYSIS CORPPJD2023-03-29
00840937103142Immunalysis IMMUNALYSIS CORPORATIONPJD2023-03-29
00840937112069QuantisalIMMUNALYSIS CORPORATIONPJD2020-10-06
00840937112144ImmunalysisIMMUNALYSIS CORPPJD2020-08-31
00840937112151QuantisalIMMUNALYSIS CORPORATIONPJD2020-08-31
00840937112168QuantisalIMMUNALYSIS CORPORATIONPJD2020-08-31
00608337000115OraSure Oral Fluid Collection DeviceOrasure Technologies, Inc.PJD2019-02-15
20608337000119OraSure Oral Fluid Collection DeviceOrasure Technologies, Inc.PJD2019-02-15
10859952006236Oral-EzeCAPITOL VIAL, INC.PJD2018-08-31
30859952006261Oral-EzeCAPITOL VIAL, INC.PJD2018-08-31
00840937110812ImmunalysisIMMUNALYSIS CORPPJD2018-04-20
00840937110829ImmunalysisIMMUNALYSIS CORPPJD2018-04-20
10859952006045Oral-EzeCAPITOL VIAL, INC.PJD2018-01-12
00884883012639Oral-Eze Sample ExtractorMicrogenics CorporationPJD2017-12-20
00884883012646Oral-Eze Sample ExtractorMicrogenics CorporationPJD2017-12-20
00859952006093Oral-EzeCAPITOL VIAL, INC.PJD2017-07-25
00859952006109Oral-EzeCAPITOL VIAL, INC.PJD2017-07-25
00859952006055Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006062Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006079Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00859952006086Oral-EzeCAPITOL VIAL, INC.PJD2017-04-27
00884883012585Oral-Eze Collection SystemMicrogenics CorporationPJD2016-09-12
00884883012653Oral-Eze Collection SystemMicrogenics CorporationPJD2016-09-12
00859952006000Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006017Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006024Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00859952006031Oral-EzeCAPITOL VIAL, INC.PJD2016-09-10
00840937105078ImmunalysisIMMUNALYSIS CORPPJD2016-08-31