FDA.reportPublic FDA data

Intercept i2 Oral Fluid Collection Device

Primary DI
00608337000917
Brand
Intercept i2 Oral Fluid Collection Device
Company
Orasure Technologies, Inc.
Model
3001-2661
Published
2016-07-29
Public version status
Update
Distribution status
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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608337000914PackageGS150In Commercial Distribution
30608337000918PackageGS1100In Commercial Distribution
00608337000917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060833700091410608337000914
3060833700091830608337000918
00608337000917006083370009176083370009170608337000917

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent tipped applicator, non-sterileA device intended for medical purposes which include, to apply medications to, or to take specimens from, a patient or an object. It is typically designed as an absorbent, non-sterile, swab on a wooden, paper, or plastic stick. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608337000115OraSure Oral Fluid Collection Device3001-28702019-02-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380008761CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380008785CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380036467CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380073714CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380084451CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380169004CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
00810111410861LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDNNK2026-08-07
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17