FDA UDI
In Commercial Distribution
🇺🇸 United States
Panther Fusion®
DI: 15420045517509
·
Model: GI EXP BAC RGNT CARTRIDGES, 96-TEST, FUSION, IVD
·
Hologic, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Panther Fusion®
- Primary DI
- 15420045517509
- Version / Model
- GI EXP BAC RGNT CARTRIDGES, 96-TEST, FUSION, IVD
- Catalog Number
- PRD-07121
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- 158b4526-b7ac-4163-8259-78ef9b1adcc9
Device Description
Panther Fusion GI Expanded Bacterial Assay, 96 tests.
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 |
|---|---|---|---|---|
| OOI | real time Nucleic acid amplification system | Clinical Chemistry | 862.2570 | 2 |
| PCH | Gastrointestinal pathogen panel multiplex nucleic acid-based assay system | Microbiology | 866.3990 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47381 | Multiple-genus gastrointestinal disease-associated bacteria 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 bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045517509 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251993 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius