Streck Cell Preservative

Basic Information

• Brand Name: Streck Cell Preservative
• Primary DI: 10844509000843
• Version / Model: 213350
• Catalog Number: 213350
• Company Name: STRECK, INC.
• Labeler DUNS: 072915986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dcf343f7-b478-4ac9-8251-1ad6d97db486

Device Description

An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains six (6) 1.0 ml vials.

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• 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
LEA	Preservative, Cytological	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41413	Lymphocyte stabilization reagent IVD	A substance or reactant intended to be used for the stabilization, preservation and/or storage of lymphocytes following separation from a whole blood clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10844509000843	GS1
Unit of Use	00844509000846	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1.0	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius