Abbott

Basic Information

• Brand Name: Abbott
• Primary DI: 00884999031357
• Version / Model: 8L49-030
• Catalog Number: 8L49-30
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-15
• Public Version: 4
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: 6aa12372-f0a2-435e-8496-a9dd117f1e6b

Device Description

DNA Amp Check

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62400	Endogenous DNA/RNA internal control IVD, reagent	A substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), and/or verify the absence of inhibiting substances, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999031357	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: -10 Degrees Celsius