T2Bacteria® QCheck Positive Kit
GUDID M70885080730
Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control Multiple bloodstream bacteria nucleic acid IVD, control| Primary Device ID | M70885080730 |
| NIH Device Record Key | 4349b96f-c6df-42bb-a2f4-049d17c90036 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2Bacteria® QCheck Positive Kit |
| Version Model Number | 85-08073 |
| 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 | true |
| 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 |
Device Dimensions
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M70885080730 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172708
FDA Product Code
| QBX | Direct Blood Bacterial Nucleic Acid Detection System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-28 |
| Device Publish Date | 2024-02-20 |
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 | 2024-02-28Positive ASK Control, Positive EPE Control |
| 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 |
| 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 [T2Bacteria]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2BACTERIA 85872740 5237320 Live/Registered |
T2 Biosystems, Inc. 2013-03-11 |
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