Search-Cyte Pool 0.8%

Basic Information

• Brand Name: Search-Cyte Pool 0.8%
• Primary DI: 07640137341596
• Version / Model: 3x10 ml
• Catalog Number: 213289
• Company Name: Medion Grifols Diagnostics AG
• Labeler DUNS: 483287020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-09
• Public Version: 2
• Public Version Date: 2025-05-13
• Public Version Status: Update
• Public Device Record Key: 8c2c0a7f-924e-4ebd-9107-92e583b1cb04

Device Description

Reagent Red Blood Cells for use in the detection of unexpected antibodies in gel technique. For in vitro diagnostic use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52690	Pooled antibody screening reagent red blood cell IVD, antigen	A collection of two or three specifically characterized reagent red blood cells pooled together into a single sample, and intended to be used in screening a clinical specimen to detect antibodies to red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640137341596	GS1