RNARetain

Basic Information

• Brand Name: RNARetain
• Primary DI: 00863840000285
• Version / Model: 84001
• Catalog Number: 84001
• Company Name: ASURAGEN, INC.
• Labeler DUNS: 622988330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-05
• Public Version: 3
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 368271f9-d4bc-4c5d-8fbe-0d2bf65866d8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZF	Tissue Rna Preservative For Collection, Storage, And Transportation	Immunology	866.4070	2

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
Primary	00863840000285	GS1

Premarket Submissions

Submission Number	Supplement Number
K113420	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius