OMNIgene ORAL

GUDID 10627595001136

Nucleic Acids Specimen Collection and Stabilization, Saliva.

DNA Genotek Inc

Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium Oral/respiratory tract specimen container IVD, additive/medium
Primary Device ID10627595001136
NIH Device Record Key0bf02061-1ee4-4641-8f3c-1a496f1b78a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNIgene ORAL
Version Model NumberOME-505
Company DUNS207983508
Company NameDNA Genotek Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com
Phone1-866-813-6354
Emailinfo@dnagenotek.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100627595000675 [Primary]
GS100627595000798 [Package]
Contains: 00627595000675
Package: OME-505.005 [1 Units]
In Commercial Distribution
GS110627595000795 [Package]
Contains: 00627595000798
Package: OME-505.005+ACP119 [1 Units]
In Commercial Distribution
GS110627595001136 [Package]
Contains: 00627595000675
Package: SOF-8010 [1 Units]
In Commercial Distribution

FDA Product Code

LIODevice, Specimen Collection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

Devices Manufactured by DNA Genotek Inc

00627595000682 - Accessory Sponges2022-11-29 DNA Assisted Collection, Sponges
10627595000313 - ORAcollect Dx2022-11-28 DNA Specimen Collection, Saliva
00627595000415 - PrepIT L2P2022-11-28 DNA Preparation Kit, 5 ml
00627595000422 - PrepIT L2P2022-11-28 DNA Preparation Kit, 45 ml
00627595000774 - OMNIgene GUT Dx2022-11-28 Microbial DNA Collection and Stabilization, Human Fecal Samples
00627595000545 - OMNIgene Liquefaction Reagent2022-11-28 Microbial DNA Stool Sample Processing, Reagent 200mL
00627595000552 - OMNIgene Liquefaction Reagent2022-11-28 Microbial DNA Stool Sample Processing, Reagent 800mL
10627595001136 - OMNIgene ORAL2022-11-28Nucleic Acids Specimen Collection and Stabilization, Saliva.
10627595001136 - OMNIgene ORAL2022-11-28 Nucleic Acids Specimen Collection and Stabilization, Saliva.

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