Negative Serum Control

Basic Information

• Brand Name: Negative Serum Control
• Primary DI: 10888234500414
• Version / Model: 403623
• Catalog Number: 403623
• Company Name: IMMUCOR GTI DIAGNOSTICS, INC.
• Labeler DUNS: 606034197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 5
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: d458e0f0-7d25-46db-a6b7-8184d0b3ecb2

Device Description

For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	864.7695	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56096	Platelet factor 4 IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of platelet factor 4 in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234500414	GS1

Customer Contacts

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

Storage Conditions

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