Primary Device ID | M70885083760 |
NIH Device Record Key | d3c8d86c-a395-4922-ad04-e118f04db99f |
Commercial Distribution Discontinuation | 2020-02-18 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | T2Dx® QCheck Negative Kit |
Version Model Number | 85-08376 |
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 |
Phone | 877-504-8282 |
t2service@t2biosystems.com |
Total Volume | 4 Milliliter |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M70885083760 [Primary] |
PII | Candida Species Nucleic Acid Detection System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-19 |
Device Publish Date | 2018-06-25 |
M70885083760 | Negative Control |
M70885083763 | Negative Control |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
T2DX 77521306 4142915 Live/Registered |
T2 BIOSYSTEMS, INC. 2008-07-14 |