FDA UDI
In Commercial Distribution
🇺🇸 United States
Clostridium difficile (CDF) Amplification Tray
DI: 00840487101704
·
Model: 20-011-022
·
LUMINEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clostridium difficile (CDF) Amplification Tray
- Primary DI
- 00840487101704
- Version / Model
- 20-011-022
- Catalog Number
- 20-011-022
- Company Name
- LUMINEX CORPORATION
- Labeler DUNS
- 080778937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-05
- Public Version
- 2
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 723f2fb7-da70-4eec-a635-8a2cee5fe707
Device Description
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59859 | Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray | 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 associated with gastrointestinal disease, in a clinical specimen, using a microarray method. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00857573006317 | GS1 | ||||
| Primary | 00840487101704 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123197 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: -20 Degrees Celsius