FDA UDI
In Commercial Distribution
🇺🇸 United States
Portrait Toxigenic C. difficile Assay
DI: B178GBCDIFF100
·
Model: GBCDIFF-10
·
GREAT BASIN SCIENTIFIC, INC.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Portrait Toxigenic C. difficile Assay
- Primary DI
- B178GBCDIFF100
- Version / Model
- GBCDIFF-10
- Catalog Number
- GBCDIFF-10
- Company Name
- GREAT BASIN SCIENTIFIC, INC.
- Labeler DUNS
- 827115259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e9e7e8d7-7858-4547-96d9-9009bcb4e1ff
Device Description
C. diff Assay Cartridge and Sample Prep Device.
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 |
|---|---|---|---|---|
| OZN | C.Difficile Toxin Gene Amplification Assay | Microbiology | 866.3130 | 2 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50836 | Clostridium difficile 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 specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B. | No | Active |
| 61735 | Clostridium difficile toxin B 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 which encodes for toxin B production from Clostridium difficile bacteria in a clinical specimen, using a nucleic acid technique (NAT). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B178GBCDIFF100 | HIBCC | ||||
| Package | B178GBCDIFF102 | HIBCC | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- (888) 333-9763
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius