QIAGEN Proteinase K

Basic Information

• Brand Name: QIAGEN Proteinase K
• Primary DI: 04053228002758
• Version / Model: 1
• Catalog Number: 19134
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d2fbf59e-a8f2-43a9-9f0d-811cf6cf6576

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
62498	PCR/NAT protease reagent IVD	A substance or reactant intended to be used as a proteolytic enzyme (e.g., proteinase K) to digest proteins in a clinical specimen. It is used to aid in the extraction of nucleic acids for subsequent analysis using a nucleic acid technique (NAT) [e.g., polymerase chain reaction (PCR), in situ hybridization (ISH)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228002758	GS1