T2Candida® Reagent Trays
GUDID M70880016893
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
Multiple Candida species nucleic acid IVD, reagent| Primary Device ID | M70880016893 |
| NIH Device Record Key | d3bc7271-de7f-4233-bbd2-29de4ae036a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2Candida® Reagent Trays |
| Version Model Number | 80-01689 |
| Company DUNS | 803126320 |
| Company Name | T2 BIOSYSTEMS, INC. |
| Device Count | 12 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | |
| 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 Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M70880009660 [Unit of Use] |
| HIBCC | M70880016893 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN140019
FDA Product Code
| PII | Candida Species Nucleic Acid Detection System |
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 | 2024-09-19 |
| Device Publish Date | 2017-02-12 |
Devices Manufactured by T2 BIOSYSTEMS, INC.
| M70880016893 - T2Candida® Reagent Trays | 2024-09-19The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel. |
| M70880016893 - T2Candida® Reagent Trays | 2024-09-19 The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel. |
| 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® | 2022-09-16 Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top ho |
Trademark Results [T2Candida]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2CANDIDA 86014788 4501051 Live/Registered |
T2 Biosystems, Inc. 2013-07-19 |
 T2CANDIDA 85978323 4290349 Live/Registered |
T2 Biosystems, Inc. 2011-08-05 |
 T2CANDIDA 85390680 not registered Dead/Abandoned |
T2 Biosystems, Inc. 2011-08-05 |
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