ZEUS Scientific Tissue Fixative

Basic Information

• Brand Name: ZEUS Scientific Tissue Fixative
• Primary DI: 00845533001793
• Version / Model: 0102
• Catalog Number: 0102
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 920a7910-ed68-480b-a7c8-0a6685461d50

Device Description

The ZEUS Tissue Fixative and Wash Solution is intended for transporting and processing fresh skin, kidney tissue, muscle, and benign or malignant lymphoid tissue when performing immunohistochemical examinations, and is for In Vitro diagnostic use only.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
57749	Michel’s solution IVD	A solution typically containing an anti-autolytic agent and ammonium sulfate intended to be used as a fixative in the processing of biological tissues and clinical specimens. Michel?s solution is generally used for fixation of tissue-bound immunoglobulins and aids in the diagnosis of certain skin diseases including pemphigus, dermatitis herpetiformis, and kidney diseases such as glomerulonephritis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533001793	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius