SpeciMAX Dx Saliva Collection Kit

Basic Information

• Brand Name: SpeciMAX Dx Saliva Collection Kit
• Primary DI: 10190302016858
• Version / Model: A51022
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 790376607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-13
• Public Version: 1
• Public Version Date: 2022-04-21
• Public Version Status: New
• Public Device Record Key: 2ad6e7b9-6f02-4525-9fd1-853344500417

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: No
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDT	CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58169	Oral/respiratory tract specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. 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
Primary	10190302016858	GS1