FDA.reportPublic FDA data

T2Biothreat® QCheck Negative Kit

Primary DI
M70885113983
Brand
T2Biothreat® QCheck Negative Kit
Company
T2 BIOSYSTEMS, INC.
Model
85-11398
Device description
Negative quality control for T2Biothreat Panel
Published
2023-11-07
Public version status
New
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
NSUInstrumentation For Clinical Multiplex Test Systems
QBXDirect Blood Bacterial Nucleic Acid Detection System
QVRMultiplex Nucleic Acid Detection System For Biothreat Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
QBXDirect Blood Bacterial Nucleic Acid Detection SystemMicrobiology2
QVRMultiplex Nucleic Acid Detection System For Biothreat AgentsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231336000T2 Biothreat PanelT2biosystems, Inc.2023-09-15QVR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M70885113983PrimaryHIBCC0
M70883113970Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(877) 504-8282t2service@t2biosystems.com

Regulatory Flags#

DUNS number
803126320
Device count
8
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M70890078170T2Candida® 1.1 Cartridge Kit90-078172018-06-25
M70880016893T2Candida® Reagent Trays80-016892017-02-12
M70890017940T2Candida® Cartridge Kit90-017942017-02-12
M70880080723T2Bacteria® Reagent Trays80-080722024-02-20
M70880080720T2Bacteria® Reagent Trays80-080722024-02-20
M70885080730T2Bacteria® QCheck Positive Kit85-080732024-02-20
M70885080743T2Bacteria® QCheck Negative Kit 85-080742018-08-02
M70890080710T2Bacteria® Cartridge Kit90-080712018-08-02
M70880113943T2Biothreat® Reagent Trays80-113942023-11-07
M70885113963T2Biothreat® QCheck Positive Kit 85-113962023-11-07
M70890114000T2Biothreat® Cartridge Kit90-114002023-11-07
M70880113930T2Biothreat® Reagent Trays80-113942023-11-07
M70883113950T2Biothreat® QCheck Positive Kit 85-113962023-11-07
M70883113970T2Biothreat® QCheck Negative Kit85-113982023-11-07
M70870049330T2Dx®70-049332017-02-12
M70880073423T2Bacteria® Reagent Trays80-073422018-08-02
M70885083763T2Dx® QCheck Negative Kit 85-083762020-02-18
M70885083760T2Dx® QCheck Negative Kit 85-083762018-06-25
M70885071910T2Bacteria® QCheck Positive Kit85-071912018-08-02
M70885083750T2Candida® QCheck Positive Kit85-083752018-06-25

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