FDA UDI
In Commercial Distribution
🇺🇸 United States
T2Biothreat® Reagent Trays
DI: M70880113943
·
Model: 80-11394
·
T2 BIOSYSTEMS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- T2Biothreat® Reagent Trays
- Primary DI
- M70880113943
- Version / Model
- 80-11394
- Company Name
- T2 BIOSYSTEMS, INC.
- Labeler DUNS
- 803126320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2023-11-07
- Public Version
- 1
- Public Version Date
- 2023-11-15
- Public Version Status
- New
- Public Device Record Key
- 93caf9d2-2a28-4dd0-81fe-37abe0c1dd92
Device Description
The T2Biothreat Panel component that contains the assay reagent
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | Immunology | 866.4000 | 2 |
| QBX | Direct Blood Bacterial Nucleic Acid Detection System | Microbiology | 866.3960 | 2 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62711 | Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen, using a nucleic acid technique (NAT). It is typically used to aid diagnosis incidences of suspected exposure to biological agents used in bioterrorism or biological warfare. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | M70880113930 | HIBCC | ||||
| Primary | M70880113943 | HIBCC |
Customer Contacts
- Phone
- (877) 504-8282
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231336 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius