FDA UDI
In Commercial Distribution
🇺🇸 United States
Enteric Pathogens (EP) Amplification Tray
DI: 00840487101544
·
Model: 20-011-023
·
LUMINEX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Enteric Pathogens (EP) Amplification Tray
- Primary DI
- 00840487101544
- Version / Model
- 20-011-023
- Catalog Number
- 20-011-023
- 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
- 5a62a71d-5795-46e8-9911-a5bd5c9cef32
Device Description
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
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 |
|---|---|---|---|---|
| PCH | Gastrointestinal pathogen panel multiplex nucleic acid-based assay system | Microbiology | 866.3990 | 2 |
| PCI | Gastrointestinal bacterial panel multiplex nucleic acid-based assay system | Microbiology | 866.3990 | 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 | 00857573006089 | GS1 | ||||
| Primary | 00840487101544 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140083 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: -20 Degrees Celsius