FDA.reportPublic FDA data

T2Biothreat® QCheck Positive Kit

Primary DI
M70883113950
Brand
T2Biothreat® QCheck Positive Kit
Company
T2 BIOSYSTEMS, INC.
Model
85-11396
Device description
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
Published
2023-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVRMultiplex Nucleic Acid Detection System For Biothreat Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
M70885113963PrimaryHIBCC0
M70883113950Unit 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
803126320
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M70870049330T2Dx®70-049332017-02-12
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
M70885113983T2Biothreat® QCheck Negative Kit85-113982023-11-07
M70890114000T2Biothreat® Cartridge Kit90-114002023-11-07
M70880113930T2Biothreat® Reagent Trays80-113942023-11-07
M70883113970T2Biothreat® QCheck Negative Kit85-113982023-11-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M70880113943T2Biothreat® Reagent TraysT2 BIOSYSTEMS, INC.QVR2023-11-07
M70885113963T2Biothreat® QCheck Positive Kit T2 BIOSYSTEMS, INC.QVR2023-11-07
M70885113983T2Biothreat® QCheck Negative KitT2 BIOSYSTEMS, INC.QVR2023-11-07
M70890114000T2Biothreat® Cartridge KitT2 BIOSYSTEMS, INC.QVR2023-11-07
M70880113930T2Biothreat® Reagent TraysT2 BIOSYSTEMS, INC.QVR2023-11-07
M70883113970T2Biothreat® QCheck Negative KitT2 BIOSYSTEMS, INC.QVR2023-11-07
00851458005273BioFire® Global Fever Special Pathogens PanelBIOFIRE DEFENSE, LLCQVR2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCQVR2023-08-31