Aptima® PRD-05110

GUDID 15420045511880

Aptima® Specimen Transfer Kit, 100 test.

Hologic, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Primary Device ID15420045511880
NIH Device Record Key3b7be001-b734-48b9-b792-70abdcc10938
Commercial Distribution StatusIn Commercial Distribution
Brand NameAptima®
Version Model NumberAptima Specimen Transfer for Liquid Pap
Catalog NumberPRD-05110
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045511880 [Primary]

FDA Product Code

MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-03
Device Publish Date2023-10-26

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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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