FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Idylla™ Respiratory (IFV-RSV) Panel
DI: 15415219000635
·
Model: 1.0
·
Biocartis NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- Idylla™ Respiratory (IFV-RSV) Panel
- Primary DI
- 15415219000635
- Version / Model
- 1.0
- Catalog Number
- A1030/6
- Company Name
- Biocartis NV
- Labeler DUNS
- 400686169
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2018-10-23
- Public Version
- 4
- Public Version Date
- 2023-05-05
- Public Version Status
- Update
- Public Device Record Key
- 8e599c39-0e75-4adb-8dfb-38bf47bc727a
- Distribution End Date
- 2023-05-04
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 |
|---|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61527 | Multiple-type respiratory pathogen 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 types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15415219000635 | GS1 | ||||
| Unit of Use | 05415219000638 | GS1 |