Primary Device ID | 15420045512023 |
NIH Device Record Key | 2cc1b2c7-985a-4c89-90df-d52c8e9cb398 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | APTIMA |
Version Model Number | BV ASSAY, APTIMA, 100T, IVD |
Catalog Number | PRD-05186 |
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 |
Phone | +1(800)442-9892 |
CustomerSupport@hologic.com | |
Phone | +1(800)442-9892 |
CustomerSupport@hologic.com |
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 Issuing Agency | Device ID |
---|---|
GS1 | 15420045512023 [Primary] |
PMN | Assayed external control material for microbiology nucleic acid amplification (NAT) assays |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-07-10 |
Device Publish Date | 2019-07-02 |
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 |
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 |