APTIMA PRD-05188

GUDID 15420045512047

Hologic, Inc.

Multiple vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator Multiple-type vaginitis-associated organism nucleic acid IVD, calibrator
Primary Device ID15420045512047
NIH Device Record Key32b91dda-b9f3-4849-9d72-68e3191263f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPTIMA
Version Model NumberBV CALIBRATOR, APTIMA, 100T, IVD
Catalog NumberPRD-05188
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045512047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation for clinical multiplex test systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-10
Device Publish Date2019-07-02

On-Brand Devices [APTIMA]

25420045510187MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
25420045507248MULTITEST SWAB COLLECTION KIT, IVD
25420045506272APTIMA SWAB SPECIMEN COLLECTION KIT
25420045506265APTIMA URINE SPECIMEN COLLECTION KIT
25420045506258APTIMA VAGINAL SWAB COLLECTION KIT
15420045509382CLASS I CONTROL - C. GLABRATA
15420045509375CLASS I CONTROL - C. ALBICANS
15420045509368CLASS I CONTROL - G. VAGINALIS
15420045509351CLASS I CONTROL - L. CRISPATUS
15420045509191UNIVERSAL PANEL A
15420045509184M GEN PANEL B
15420045509160M GEN, CALIBRATOR 100T, AS, IVD
15420045509153BX 2 (RT) M GEN, 100T, AS, IVD
15420045509146BX 1 (REF) M GEN, 100T, AS, IVD
15420045507234APTIMA HSV TRAY, CONTROLS KIT, IVD
15420045507227APTIMA HSV ROOM TEMP BOX, 100 TESTS, IVD
15420045507210APTIMA HSV REFRIG BOX, 100 TESTS, IVD
15420045506800HCV VIRAL ASSAY CALIBRATOR, 100T, US IVD
15420045506794HCV VIRAL ASSAY CONTROLS, 100T, US IVD
15420045506787HCV VIRAL ASSAY, APTIMA, 100T, US IVD
15420045506770HBV VIRAL LOAD ASSAY TER
15420045506763HBV VIRAL LOAD ASSAY CONTROLS
15420045506756HBV VIRAL LOAD ASSAY CALIBRATORS
15420045506749HBV VIRAL ASSAY, APTIMA, 100T, US IVD
15420045506442APTIMA GPRS, 250 TESTS (REF)
15420045506435APTIMA GPRS, 250 TESTS (RT)
15420045506299APTIMA GC ASSAY SPECIFIC REAGENTS
15420045506282APTIMA GC ASSAY FLUIDS
15420045506244APTIMA URINE COLLECTION TUBES
15420045506237APTIMA CONTROLS KIT, IVD
15420045505766APTIMA TRICHOMONAS VAGINALIS CONTROLS
15420045505759APTIMA CT ASSAY SPECIFIC REAGENTS
15420045505742APTIMA CT ASSAY
15420045505735AC2, AS, 100 TESTS (REF)
15420045505728AC2, AS, 100 TESTS (RT)
15420045505711AC2, TIGRIS, 250 TESTS (REF)
15420045505704AC2, TIGRIS, 250 TESTS (RT)
15420045505551TRICHOMONAS VAGINALIS, 250T, IVD (REF)V2
15420045505544TRICHOMONAS VAGINALIS, 250T IVD (RT) V2
15420045505537TRICHOMONAS VAGINALIS, 100T, IVD (REF)V2
15420045505520TRICHOMONAS VAGINALIS, 100T, IVD (RT)V2
15420045505513TRICHOMONAS VAGINALIS, 100T, IVD (REF)V2
15420045505506TRICHOMONAS VAGINALIS, 100T, IVD (RT)V2
15420045505490TRICHOMONAS VAGINALIS, 250T, IVD (REF)V2
15420045505483TRICHOMONAS VAGINALIS, 250 T, IVD (RT)V2
15420045505476TRICHOMONAS VAGINALIS, 100 T, IVD (REF)
15420045505469TRICHOMONAS VAGINALIS, 100 T, IVD (RT)
15420045505452TRICHOMONAS VAGINALIS, 250 T, IVD (REF)
15420045505445TRICHOMONAS VAGINALIS, 250 T, IVD (RT)
15420045505438APTIMA GC, 100-TEST, AS (RT) BOX 1

Trademark Results [APTIMA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APTIMA
APTIMA
90871221 not registered Live/Pending
Aptima, Inc.
2021-08-08
APTIMA
APTIMA
78315970 2884471 Live/Registered
Gen-Probe Incorporated
2003-10-20
APTIMA
APTIMA
78151859 2840053 Live/Registered
Gen-Probe Incorporated
2002-08-07
APTIMA
APTIMA
77975375 3530982 Live/Registered
Aptima, Inc.
2007-08-29
APTIMA
APTIMA
77267375 3405210 Live/Registered
Aptima, Inc.
2007-08-29
APTIMA
APTIMA
77267356 not registered Dead/Abandoned
Aptima, Inc.
2007-08-29
APTIMA
APTIMA
76031168 2440995 Live/Registered
Aptima, Inc.
2000-04-18
APTIMA
APTIMA
75588396 2432113 Live/Registered
Gen-Probe Incorporated
1998-11-13

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