Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA. FDA UDI
- Model / Reference
- KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVD FDA UDI
- Description
- The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA. FDA UDI
Identifiers
- Catalog Number
- PRD-04484 FDA UDI
- Primary DI / UDI-DI
- 15420045510890 FDA UDI
- FDA Product Code
- OOI FDA UDINJR FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI866.3740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Xpert® — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- Alethia™ Group B Streptococcus — MERIDIAN BIOSCIENCE, INC. · Class I
- GeneXpert® — CEPHEID · Class I
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI a8e8df8f-64b4-4124-8109-58ea72deee96 36 fields · synced May 29, 2026