FDA UDI
In Commercial Distribution
🇺🇸 United States
Respiratory Pathogens Flex (RP Flex) Extraction Tray
DI: 00840487101667
·
Model: 20-009-024
·
LUMINEX CORPORATION
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Respiratory Pathogens Flex (RP Flex) Extraction Tray
- Primary DI
- 00840487101667
- Version / Model
- 20-009-024
- Catalog Number
- 20-009-024
- 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
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- cf6159c9-38e0-4911-91c2-1cffcf7d883f
Device Description
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract 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 |
|---|---|---|---|---|
| OOU | Parainfluenza multiplex nucleic acid assay | Microbiology | 866.3980 | 2 |
| OEM | Human metapneumovirus (hmpv) rna assay system | Microbiology | 866.3980 | 2 |
| OZZ | Bordetella pertussis dna assay system | Microbiology | 866.3980 | 2 |
| OCC | Respiratory virus panel nucleic acid assay system | Microbiology | 866.3980 | 2 |
| OZE | Influenza A and influenza B multiplex nucleic acid assay | Microbiology | 866.3980 | 2 |
| OEP | Influenza a virus subtype differentiation nucleic acid assay | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47922 | Multiple-genus respiratory virus 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 from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00857573006263 | GS1 | ||||
| Primary | 00840487101667 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143653 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius