MTS

Basic Information

• Brand Name: MTS
• Primary DI: 10758750005949
• Version / Model: MTS081001
• Catalog Number: MTS081001
• Company Name: MICRO TYPING SYSTEMS, INC
• Labeler DUNS: 781421888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 3
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 85f2665b-a956-4ca7-840c-369f4eaff42c

Device Description

MTS Monoclonal Control Card

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
KSF	KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52705	Antisera matrix (non-reactive) IVD, control	A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750005949	GS1

Storage Conditions

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