APTIMA

Basic Information

• Brand Name: APTIMA
• Primary DI: 25420045513720
• Version / Model: COVID TMA COLLECTION TUBES
• Catalog Number: PRD-06660
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-06-23
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 32e895fc-e15b-48d8-80d3-2a68671162c4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
NNI	CONTAINER, SPECIMEN, NON-STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63232	General specimen container IVD, additive/medium	A covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	15420045513723	GS1
Primary	25420045513720	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius