Quantisal

Primary DI
00840937112168
Brand
Quantisal
Company
IMMUNALYSIS CORPORATION
Model
QSI-0500
Catalog number
QSI-0500
Device description
Quantisal Oral Fluid Collection Device 500pk
Published
2020-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200801000Quantisal Oral Fluid Collection DeviceImmunalysis Corporation2020-07-28PJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937112168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937112168008409371121688409371121680840937112168

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840937112151QuantisalQSI-0025QSI-00252020-08-31
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
00840937106433Immunalysis CorporationFC-210-7502016-08-31

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
00840937112052QuantisalIMMUNALYSIS CORPORATIONPJD2020-10-06
00840937112069QuantisalIMMUNALYSIS CORPORATIONPJD2020-10-06
00840937112144ImmunalysisIMMUNALYSIS CORPPJD2020-08-31
00840937112151QuantisalIMMUNALYSIS 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