RealTime

Basic Information

• Brand Name: RealTime
• Primary DI: 00884999036147
• Version / Model: 08L21-80
• Catalog Number: 08L21-80
• 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: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: f383a96e-76ef-4129-b6c5-fd1eb30f3fb3

Device Description

Abbott RealTime HCV Genotype II Control Kit

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBF	Assay, genotyping, hepatitis c virus	Microbiology	866.3170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59865	Hepatitis C virus genotyping IVD, control	A material which is used to verify the performance of an assay intended to be used for the genotype determination of Hepatitis C virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999036147	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P120012	001
P120012	002
P120012	003
P120012	004
P120012	005
P120012	006
P120012	007
P120012	009
P120012	010
P120012	011
P120012	012
P120012	013
P120012	014
P120012	015
P120012	016
P120012	017
P120012	018

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius