Primary Device ID | 15420045511453 |
NIH Device Record Key | 4c3383d3-f914-4a17-a7d3-8dcfb6bad2ee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Panther Fusion® |
Version Model Number | DNA EBV PROBE (ASR) |
Catalog Number | PRD-04989 |
Company DUNS | 050579217 |
Company Name | Hologic, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045511453 [Primary] |
MVU | Reagents, specific, analyte |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-15 |
Device Publish Date | 2024-04-05 |
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. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PANTHER FUSION 86575813 5233077 Live/Registered |
Gen-Probe Incorporated 2015-03-25 |