APTIMA PRD-05188

GUDID 15420045512047

Hologic, Inc.

Multiple vaginitis-associated organism nucleic acid IVD, calibrator

• Primary Device ID: 15420045512047
• NIH Device Record Key: 32b91dda-b9f3-4849-9d72-68e3191263f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APTIMA
• Version Model Number: BV CALIBRATOR, APTIMA, 100T, IVD
• Catalog Number: PRD-05188
• 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

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045512047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190452

FDA Product Code

• NSU: Instrumentation for clinical multiplex test systems

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: 2019-07-10
• Device Publish Date: 2019-07-02

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