T2Biothreat® QCheck Negative Kit
GUDID M70883113970
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control| Primary Device ID | M70883113970 |
| NIH Device Record Key | 2b03caa2-b669-4fc5-8d9e-427b850a703c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2Biothreat® QCheck Negative Kit |
| Version Model Number | 85-11398 |
| Company DUNS | 803126320 |
| Company Name | T2 BIOSYSTEMS, INC. |
| Device Count | 8 |
| 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 -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 | M70883113970 [Unit of Use] |
| HIBCC | M70885113983 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231336
FDA Product Code
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents |
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 | 2023-11-15 |
| Device Publish Date | 2023-11-07 |
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 | 2023-11-15Negative quality control for T2Biothreat Panel |
| 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 [T2Biothreat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2BIOTHREAT 88872606 not registered Live/Pending |
T2 Biosystems, Inc. 2020-04-15 |
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