FDA UDI
In Commercial Distribution
🇺🇸 United States
Revogene C. difficile
DI: 00840733102349
·
Model: 410300
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Revogene C. difficile
- Primary DI
- 00840733102349
- Version / Model
- 410300
- Catalog Number
- 401300
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-15
- Public Version
- 1
- Public Version Date
- 2020-07-23
- Public Version Status
- New
- Public Device Record Key
- 3eae486e-3afb-4bdc-8542-51ed4fe2baca
Device Description
The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.
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 |
|---|---|---|---|---|
| OZN | C. Difficile Toxin Gene Amplification Assay | Microbiology | 866.3130 | 2 |
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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733102349 | GS1 |
Customer Contacts
- Phone
- 1-800-343-3858
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172569 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius