FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpert Carba-R
DI: 07332940001032
·
Model: GXCARBAR-10
·
CEPHEID
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xpert Carba-R
- Primary DI
- 07332940001032
- Version / Model
- GXCARBAR-10
- Catalog Number
- GXCARBAR-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
- 5
- Public Version Date
- 2021-05-24
- Public Version Status
- Update
- Public Device Record Key
- 210dc75b-dd1b-4a7d-961d-85d8afa14cdf
Device Description
Xpert Carba-R test; 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 |
|---|---|---|---|---|
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | Microbiology | 866.1640 | 2 |
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60673 | Multiple antimicrobial resistance 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 multiple genes conferring resistance to multiple antimicrobial drugs in multiple types of bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Genes detected may include, but are not limited to, carbapenemase genes (KPC, NDM, VIM, and OXA), extended spectrum beta-lactamase (ESBL)-encoding genes (e.g., TEM, SHV, IMP, NDM-1 and CTX-M) and/or vancomycin resistance genes (vanA and vanB). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332940001032 | GS1 |
Customer Contacts
- Phone
- 1 888 838 3222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173263 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius