Aptima®

Basic Information

• Brand Name: Aptima®
• Primary DI: 15420045506237
• Version / Model: APTIMA CONTROLS KIT, IVD
• Catalog Number: 301110
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-15
• Public Version: 4
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: c83e962a-273b-4a3f-ac2e-ea0eb0328017

Device Description

The Aptima® Controls Kit is for use with the Aptima® Assays for the detection of C. trachomatis and/or N. gonorrhoeae. These quality control reagents are to be used according to the instructions in the package insert of the appropriate Aptima® Assay to establish run validity.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2
QEP	Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections	Microbiology	866.3393	2
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50411	Multiple-type sexually transmitted pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045506237	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius