RealTime

Basic Information

• Brand Name: RealTime
• Primary DI: 00884999047341
• Version / Model: 08N90-080
• Catalog Number: 08N90-080
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-30
• Public Version: 3
• Public Version Date: 2020-05-25
• Public Version Status: Update
• Public Device Record Key: 1f8aa20c-a1bc-43f0-a863-00ff5d9758d6

Device Description

Abbott RealTime IDH1 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
OWD	Somatic gene mutation detection system	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60696	Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD, control	A material which is used to verify the performance of an assay intended to be used to monitor or predict the isocitrate dehydrogenase 1 (IDH1) gene mutation status of a tumour tissue specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999047341	GS1

Customer Contacts

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

Storage Conditions

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