Aptima Combo 2®

Basic Information

• Brand Name: Aptima Combo 2®
• Primary DI: 15420045505735
• Version / Model: KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD
• Catalog Number: 302931
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-11
• Public Version: 5
• Public Version Date: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: a46fd60d-b722-4555-943d-b22c3175cd5e

Device Description

Aptima Combo 2® Assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified.

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
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1
QEP	Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections	Microbiology	866.3393	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50409	Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials 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	15420045505735	GS1

Customer Contacts

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

Storage Conditions

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