Solidscreen II-Control

Basic Information

• Brand Name: Solidscreen II-Control
• Primary DI: 07611969951390
• Version / Model: 806514100
• Catalog Number: 806514100
• Company Name: Bio-Rad Medical Diagnostics GmbH
• Labeler DUNS: 312576506
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6caea2a5-62dd-49cc-b8ee-715184c03940

Device Description

Positive Control for Solidscreen II on TANGO instruments; 4 ml

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52703	Anti-Rh(D) antibody screen IVD, control	A material containing antibodies to Rh(D) red blood cell antigens [RH001] from the Rhesus system intended to be used in immunohaematological testing of a clinical specimen, to verify the performance of an antibody screening assay that is used for detecting red cell alloantibodies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969951390	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK040070	0

Storage Conditions

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