Seraclone® Anti-P1 (P1)

Basic Information

• Brand Name: Seraclone® Anti-P1 (P1)
• Primary DI: 07611969951710
• Version / Model: 808158100
• Catalog Number: 808158100
• 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: 2014-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 05b652c3-d4ba-4119-b3c7-0990b09ab712

Device Description

Blood Grouping Reagent Anti-P1 (P1); Seraclone® Murine Monoclonal (650); for tube test; 2ml

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

GMDN Terms

Code	Name	Definition	Implantable	Status
52639	Anti-P1 red blood cell grouping IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for P1 [P001] red blood cell antigens from the P system, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07611969951710	GS1

Customer Contacts

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

Storage Conditions

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