HYDRASHIFT 2 4 daratumumab 20 tests

Basic Information

• Brand Name: HYDRASHIFT 2 4 daratumumab 20 tests
• Primary DI: 03607360046395
• Version / Model: 4639
• Catalog Number: 4639
• Company Name: SEBIA
• Labeler DUNS: 276801933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 1
• Public Version Date: 2019-07-09
• Public Version Status: New
• Public Device Record Key: dae027af-0127-45a9-86b1-363f96a78250

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: Yes
• 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
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53595	Multiple clinical chemistry protein IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03607360046395	GS1

Premarket Submissions

Submission Number	Supplement Number
K190851	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius