APTIMA PRD-03706
GUDID 15420045506794
Hologic, Inc.
HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 15420045506794 |
| NIH Device Record Key | e88ba9bd-76f8-4723-a9c7-1773fa8831b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APTIMA |
| Version Model Number | HCV VIRAL ASSAY CONTROLS, 100T, US IVD |
| Catalog Number | PRD-03706 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -35 Degrees Celsius and -15 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045506794 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-08 |
On-Brand Devices [APTIMA]
| 25420045510187 | MULTITEST SWAB COLLECTION KIT,APTIMA,IVD |
| 25420045507248 | MULTITEST SWAB COLLECTION KIT, IVD |
| 25420045506272 | APTIMA SWAB SPECIMEN COLLECTION KIT |
| 25420045506265 | APTIMA URINE SPECIMEN COLLECTION KIT |
| 25420045506258 | APTIMA VAGINAL SWAB COLLECTION KIT |
| 15420045509382 | CLASS I CONTROL - C. GLABRATA |
| 15420045509375 | CLASS I CONTROL - C. ALBICANS |
| 15420045509368 | CLASS I CONTROL - G. VAGINALIS |
| 15420045509351 | CLASS I CONTROL - L. CRISPATUS |
| 15420045509191 | UNIVERSAL PANEL A |
| 15420045509184 | M GEN PANEL B |
| 15420045509160 | M GEN, CALIBRATOR 100T, AS, IVD |
| 15420045509153 | BX 2 (RT) M GEN, 100T, AS, IVD |
| 15420045509146 | BX 1 (REF) M GEN, 100T, AS, IVD |
| 15420045507234 | APTIMA HSV TRAY, CONTROLS KIT, IVD |
| 15420045507227 | APTIMA HSV ROOM TEMP BOX, 100 TESTS, IVD |
| 15420045507210 | APTIMA HSV REFRIG BOX, 100 TESTS, IVD |
| 15420045506800 | HCV VIRAL ASSAY CALIBRATOR, 100T, US IVD |
| 15420045506794 | HCV VIRAL ASSAY CONTROLS, 100T, US IVD |
| 15420045506787 | HCV VIRAL ASSAY, APTIMA, 100T, US IVD |
| 15420045506770 | HBV VIRAL LOAD ASSAY TER |
| 15420045506763 | HBV VIRAL LOAD ASSAY CONTROLS |
| 15420045506756 | HBV VIRAL LOAD ASSAY CALIBRATORS |
| 15420045506749 | HBV VIRAL ASSAY, APTIMA, 100T, US IVD |
| 15420045506442 | APTIMA GPRS, 250 TESTS (REF) |
| 15420045506435 | APTIMA GPRS, 250 TESTS (RT) |
| 15420045506299 | APTIMA GC ASSAY SPECIFIC REAGENTS |
| 15420045506282 | APTIMA GC ASSAY FLUIDS |
| 15420045506244 | APTIMA URINE COLLECTION TUBES |
| 15420045506237 | APTIMA CONTROLS KIT, IVD |
| 15420045505766 | APTIMA TRICHOMONAS VAGINALIS CONTROLS |
| 15420045505759 | APTIMA CT ASSAY SPECIFIC REAGENTS |
| 15420045505742 | APTIMA CT ASSAY |
| 15420045505735 | AC2, AS, 100 TESTS (REF) |
| 15420045505728 | AC2, AS, 100 TESTS (RT) |
| 15420045505711 | AC2, TIGRIS, 250 TESTS (REF) |
| 15420045505704 | AC2, TIGRIS, 250 TESTS (RT) |
| 15420045505551 | TRICHOMONAS VAGINALIS, 250T, IVD (REF)V2 |
| 15420045505544 | TRICHOMONAS VAGINALIS, 250T IVD (RT) V2 |
| 15420045505537 | TRICHOMONAS VAGINALIS, 100T, IVD (REF)V2 |
| 15420045505520 | TRICHOMONAS VAGINALIS, 100T, IVD (RT)V2 |
| 15420045505513 | TRICHOMONAS VAGINALIS, 100T, IVD (REF)V2 |
| 15420045505506 | TRICHOMONAS VAGINALIS, 100T, IVD (RT)V2 |
| 15420045505490 | TRICHOMONAS VAGINALIS, 250T, IVD (REF)V2 |
| 15420045505483 | TRICHOMONAS VAGINALIS, 250 T, IVD (RT)V2 |
| 15420045505476 | TRICHOMONAS VAGINALIS, 100 T, IVD (REF) |
| 15420045505469 | TRICHOMONAS VAGINALIS, 100 T, IVD (RT) |
| 15420045505452 | TRICHOMONAS VAGINALIS, 250 T, IVD (REF) |
| 15420045505445 | TRICHOMONAS VAGINALIS, 250 T, IVD (RT) |
| 15420045505438 | APTIMA GC, 100-TEST, AS (RT) BOX 1 |
Trademark Results [APTIMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APTIMA 90871221 not registered Live/Pending |
Aptima, Inc. 2021-08-08 |
 APTIMA 78315970 2884471 Live/Registered |
Gen-Probe Incorporated 2003-10-20 |
 APTIMA 78151859 2840053 Live/Registered |
Gen-Probe Incorporated 2002-08-07 |
 APTIMA 77975375 3530982 Live/Registered |
Aptima, Inc. 2007-08-29 |
 APTIMA 77267375 3405210 Live/Registered |
Aptima, Inc. 2007-08-29 |
 APTIMA 77267356 not registered Dead/Abandoned |
Aptima, Inc. 2007-08-29 |
 APTIMA 76031168 2440995 Live/Registered |
Aptima, Inc. 2000-04-18 |
 APTIMA 75588396 2432113 Live/Registered |
Gen-Probe Incorporated 1998-11-13 |
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