FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpert MTB/RIF
DI: 07332940000912
·
Model: GXMTB/RIF-US-10
·
CEPHEID
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xpert MTB/RIF
- Primary DI
- 07332940000912
- Version / Model
- GXMTB/RIF-US-10
- Catalog Number
- GXMTB/RIF-US-10
- Company Name
- CEPHEID
- Labeler DUNS
- 956711444
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 3
- Public Version Date
- 2022-05-03
- Public Version Status
- Update
- Public Device Record Key
- 09520b37-90cc-4328-b145-8891f3a588fe
Device Description
Xpert MTB/RIF kit; 10 test kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | Microbiology | 866.3373 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61517 | MDR-TB/XDR-TB 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, including genes conferring resistance to antimicrobial drugs, from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, as a marker for multi-drug resistant tuberculosis (MDR-TB) or extensively drug-resistant tuberculosis (XDR-TB), using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332940000912 | GS1 |
Customer Contacts
- Phone
- 1 888 838 3222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN130032 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius