FDA.reportPublic FDA data

OraSure Oral Fluid Collection Device

Primary DI
00608337000115
Brand
OraSure Oral Fluid Collection Device
Company
Orasure Technologies, Inc.
Model
3001-2870
Published
2019-02-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608337000112PackageGS150Not in Commercial Distribution
20608337000119PackageGS1500Not in Commercial Distribution
00608337000115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060833700011210608337000112
2060833700011920608337000119
00608337000115006083370001156083370001150608337000115

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kitA 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
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
610-882-1820customercare@orasure.com

Regulatory Flags#

DUNS number
114152184
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608337000559Histofreezer1001-03752016-09-15
00608337360103Histofreezer1001-02952016-09-15
00608337365108Histofreezer1001-02942016-09-15
00608337402100Histofreezer1001-02932016-09-15
20608337000065OraSure Quick Flu 22-Count Flu A + B Kit1001-03202016-11-10
00608337000047OraSure Quickflu Nasopharyngeal Wash / Aspirate1001-03212016-11-25
00608337000054OraSure QuickFlu Positive and Negative Control Kit1001-03232018-03-23
00608337001297Histofreezer1001-03362016-09-16
10608337001850OraQuick HIV Self-Test3001-3822U22026-05-08
00608337001860OraQuick HIV Self-Test3001-3822UR22026-05-08
00608337000078Intercept3001-28692016-07-29
00608337150308Q.E.D. Saliva Alcohol Test A150601562016-07-29
00608337000030Kit, MP Cotinine Serum 100 plate1124EC2021-01-22
00608337000023Methamphetamine Intercept 2 Plate Kit1104IT2016-09-12
00608337000085Auto-Lyte1224UM1224UM2016-04-29
00608337000146Amphetamine Intercept 5 Plate Kit1103IB2016-09-12
00608337000153Amphetamine Intercept 100 Plate Kit1103IC2016-09-12
00608337000184Methamphetamine Intercept 5 Plate Kit1104IB2016-09-12
00608337000191Methamphetamine Intercept 100 Plate Kit1104IC2016-09-12
00608337000207Barbiturates Intercept 5 Plate Kit1108IB2016-09-12

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
00840937112168QuantisalIMMUNALYSIS CORPORATIONPJD2020-08-31
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