FDA.reportPublic FDA data

T2Dx®

Primary DI
M70870049330
Brand
T2Dx®
Company
T2 BIOSYSTEMS, INC.
Model
70-04933
Device description
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140019000T2CANDIDA AND T2DX INSTRUMENTT2biosystems, Inc.2014-09-22PII

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M70870049330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic separation instrument IVD, molecularAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques. It is a software-controlled, liquid handling robotic instrument that processes solutions using sequential immersion of magnetized rods, to attract labelled molecules, and rotation of demagnetized rods to create a new suspension/solution, and is typically used for nucleic acid isolation procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
803126320
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
M70883113950T2Biothreat® QCheck Positive Kit 85-113962023-11-07
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

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