FDA.reportPublic FDA data

SalivaGene Collector

Primary DI
04250306301219
Brand
SalivaGene Collector
Company
Invitek Molecular GmbH
Model
SalivaGene
Catalog number
1035211200
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250306301219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250306301219042503063012194250306301219

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
331869789
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250306300724InviMag Universal Kit /KF96InviMag74503002002025-04-01
04250306300823InviMag Universal Kit /KF96 w/o plasticInviMag74503002502025-04-01
04250306300212InviTrap Spin Universal RNA Kit (50)50 prep10601002002025-01-20
04250306300229InviTrap Spin Universal RNA Kit (250)250 prep10601003002025-01-20
04250306300311RTP Pathogen Kit (50)50 prep10405002002025-01-20
04250306300328RTP Pathogen Kit (250)250 prep10405003002025-01-20
04250306300410PSP Spin Stool DNA Basic Kit (50)50 prep10381202002025-01-20
04250306300427PSP Spin Stool DNA Basic Kit (250)250 prep10381203002025-01-20
04250306300922PSP SalivaGene DNA Kit (250)250 prep10352003002025-01-20
04250306301110SalivaGene Swab ComfortSalivaGene10352311002024-11-20
04250306300915PSP SalivaGene DNA Kit 50 prep10352002002024-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
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00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
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00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06