Panther Fusion® PRD-07401
GUDID 15420045515376
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.
Hologic, Inc.
Multiple respiratory virus nucleic acid IVD, control| Primary Device ID | 15420045515376 |
| NIH Device Record Key | 216d08a4-30dd-4385-9b71-866f3a006a37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Panther Fusion® |
| Version Model Number | KIT, SARS/FLU A/B/RSV CONTROLS, FUSION, IVD |
| Catalog Number | PRD-07401 |
| Company DUNS | 050579217 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045515376 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222736
FDA Product Code
| QOF | Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
On-Brand Devices [Panther Fusion®]
| 15420045516168 | Oil Reagent. |
| 15420045515451 | Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests. |
| 15420045515376 | Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit. |
| 15420045515352 | Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, 96 tests. |
| 15420045511415 | The RNA IC Probe ASR contains an oligonucleotide designed to detect the RNA target present in th |
| 15420045511408 | The DNA IC Probe ASR contains an oligonucleotide designed to detect the DNA target present in th |
| 15420045511392 | The RNA IC Primers ASR contains forward and reverse primers designed to amplify the RNA target p |
| 15420045511088 | The DNA IC Primers ASR contains forward and reverse primers designed to amplify the DNA targets |
| 15420045512139 | Hologic BKV Plasmid Control. |
| 15420045511477 | BK virus (BKV) Probe ASR. |
| 15420045511460 | BK virus (BKV) Primers ASR. |
| 15420045510906 | Panther Fusion® GBS Controls Kit. |
| 15420045510463 | Panther Fusion® Extraction Reagent-X. |
| 15420045510920 | Specimen Transport Medium. |
| 15420045512122 | Hologic EBV Plasmid Control. |
| 15420045511590 | Group A Strep (GAS) Primers ASR. |
| 15420045511576 | Group A Strep (GAS) Probe ASR. |
| 15420045511552 | Hologic GAS Plasmid Control. |
| 15420045511453 | Epstein-Barr virus (EBV) Probe ASR. |
| 15420045511446 | Epstein-Barr virus (EBV) Primers ASR. |
| 15420045511071 | Panther Fusion® Open Access® Diluent Additive. |
| 15420045510944 | Blood Transport Medium. |
| 15420045510937 | Urine Transport Medium. |
| 15420045512146 | Hologic VZV Plasmid Control. |
| 15420045512115 | Hologic CMV Plasmid Control. |
| 15420045511491 | Varicella zoster virus (VZV) Probe ASR. |
| 15420045511484 | Varicella zoster virus (VZV) Primers ASR. |
| 15420045511439 | Cytomegalovirus (CMV) Probe ASR. |
| 15420045511422 | Cytomegalovirus (CMV) Primers ASR. |
| 15420045510890 | The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing re |
| 15420045510470 | Panther Fusion® Internal Control-X. |
Trademark Results [Panther Fusion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PANTHER FUSION 86575813 5233077 Live/Registered |
Gen-Probe Incorporated 2015-03-25 |
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