RealTime

Basic Information

• Brand Name: RealTime
• Primary DI: 00884999037434
• Version / Model: 1N30-67
• Catalog Number: 1N30-67
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 86bd2259-faf3-478c-9b62-2f14a0af2839

Device Description

Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
MZP	ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS	Microbiology	866.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61119	DNA anti-contamination enzyme reagent IVD	A substance or reactant intended to be used as a hydrolyzing enzyme in a molecular assay to prevent contamination of the resulting deoxyribonucleic acid (DNA) amplicon, by preventing unintentional carry over of amplification products from a previous assay, in the analysis of a clinical laboratory specimen, using a polymerase chain reaction (PCR) technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999037434	GS1

Customer Contacts

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