FDA.reportPublic FDA data

OMNIgene Liquefaction Reagent

Primary DI
00627595000545
Brand
OMNIgene Liquefaction Reagent
Company
DNA Genotek Inc
Model
OM-LQR-400
Device description
Microbial DNA Stool Sample Processing, Reagent 200mL
Published
2022-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627595000545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627595000545006275950005456275950005450627595000545

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-813-6354info@dnagenotek.com

Regulatory Flags#

DUNS number
207983508
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627595000279Oragene DxOXD-5002025-09-08
00627595000286Oragene DxOYD-5002025-09-08
00627595001627Colli-PeeColli-Pee FV-5020N000552024-12-09
00627595001634Colli-PeeColli-Pee FV-5010N003092024-12-09
00627595001641Colli-PeeColli-Pee FV-5020cN002382024-12-09
00627595001658Colli-PeeColli-Pee FV-5004N002902024-12-09
00627595001665Colli-PeeColli-Pee FV-5040N002692024-12-09
00627595001672Colli-PeeColli-Pee UCM FV-5020N001762024-12-09
00627595001689Colli-PeeColli-Pee UCM FV-5010N003272024-12-09
00627595001696Colli-PeeColli-Pee UCM FV-5003bN003832024-12-09
00627595001702Colli-PeeColli-Pee UCM FV-5004N002602024-12-09
00627595001719Colli-PeeColli-Pee UAS FV-5040N003422024-12-09
00627595000507OMNIgene GUT DxOMD-2002022-11-18
00627595000712ORAcollect DxOCD-100.0142022-11-18
00627595000132Oragene DxOGD-5102016-09-08
00627595000248Oragene DxOGD-6002016-09-09
00627595000255Oragene DxOGD-6102016-09-09
00627595000309ORAcollect DxOCD-1002016-09-10
00627595000682Accessory SpongesOG-AC12022-11-21
00627595000316ORAcollect DxOCD-100A2022-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017133Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08