FDA UDI
In Commercial Distribution
🇺🇸 United States
Panther Fusion®
DI: 15420045509221
·
Model: KIT, INTERNAL CONTROL -S, FUSION, IVD
·
Hologic, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Panther Fusion®
- Primary DI
- 15420045509221
- Version / Model
- KIT, INTERNAL CONTROL -S, FUSION, IVD
- Catalog Number
- PRD-04332
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-08
- Public Version
- 7
- Public Version Date
- 2024-06-13
- Public Version Status
- Update
- Public Device Record Key
- 80155078-70ef-452f-9471-48e12b605033
Device Description
Panther Fusion® Internal Control-S.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OEM | Human metapneumovirus (hmpv) rna assay system | Microbiology | 866.3980 | 2 |
| OOU | Parainfluenza multiplex nucleic acid assay | Microbiology | 866.3980 | 2 |
| QOF | Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents | Microbiology | 866.3981 | 2 |
| OCC | Respiratory virus panel nucleic acid assay system | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60094 | Exogenous DNA/RNA internal control IVD, kit | A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or to verify the absence of inhibiting substances in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045509221 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius