T2Dx®
GUDID M70870049330
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
T2 BIOSYSTEMS, INC.
Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD Magnetic particle separation instrument IVD| Primary Device ID | M70870049330 |
| NIH Device Record Key | d79278b6-8e36-4a3f-b952-afe946d12144 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2Dx® |
| Version Model Number | 70-04933 |
| Company DUNS | 803126320 |
| Company Name | T2 BIOSYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com | |
| Phone | 877-504-8282 |
| t2service@t2biosystems.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M70870049330 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN140019
FDA Product Code
| NSU | Instrumentation For Clinical Multiplex Test Systems |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-09-16 |
| Device Publish Date | 2017-02-12 |
Devices Manufactured by T2 BIOSYSTEMS, INC.
| M70880080720 - T2Bacteria® Reagent Trays | 2024-02-28 The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel. |
| M70885080730 - T2Bacteria® QCheck Positive Kit | 2024-02-28 Positive ASK Control, Positive EPE Control |
| M70885080743 - T2Bacteria® QCheck Negative Kit | 2024-02-16 Negative Control for T2Bacteria Panel |
| M70880113930 - T2Biothreat® Reagent Trays | 2023-11-15 The T2Biothreat Panel component that contains the assay reagent |
| M70883113950 - T2Biothreat® QCheck Positive Kit | 2023-11-15 Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences. |
| M70883113970 - T2Biothreat® QCheck Negative Kit | 2023-11-15 Negative quality control for T2Biothreat Panel |
| M70870049330 - T2Dx® | 2022-09-16Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing. |
| M70870049330 - T2Dx® | 2022-09-16 Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top ho |
| M70890017940 - T2Candida® Cartridge Kit | 2022-04-28 The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida p |
Trademark Results [T2Dx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2DX 77521306 4142915 Live/Registered |
T2 BIOSYSTEMS, INC. 2008-07-14 |
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