FDA UDI
In Commercial Distribution
🇺🇸 United States
ePlex System
DI: 00857167005030
·
Model: ePlex Respiratory Panel (RP)
·
GENMARK DIAGNOSTICS, INC.
Product Codes
9
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ePlex System
- Primary DI
- 00857167005030
- Version / Model
- ePlex Respiratory Panel (RP)
- Catalog Number
- EA001012
- Company Name
- GENMARK DIAGNOSTICS, INC.
- Labeler DUNS
- 962104217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-29
- Public Version
- 5
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 54c96299-7b9d-4627-b15a-703efee6e057
Device Description
ePlex Respiratory Panel Kit, 12 test, IVD
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 |
|---|---|---|---|---|
| OZY | Chlamydophila Pneumoniae Dna Assay System | Microbiology | 866.3980 | 2 |
| OZX | Mycoplasma Pneumoniae Dna Assay System | Microbiology | 866.3980 | 2 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | Microbiology | 866.3332 | 2 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | Microbiology | 866.3980 | 2 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48245 | Multiple-genus respiratory virus antigen IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857167005030 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163636 | 000 |