MTS

Basic Information

• Brand Name: MTS
• Primary DI: 10758750006007
• Version / Model: MTS085014
• Catalog Number: MTS085014
• 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: 4
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 88b0c2e0-4dd4-4625-9208-09cbb18e9e5b

Device Description

MTS Buffered Gel 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
KSZ	SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52710	Column agglutination IVD	A non-reactive suspension medium containing beaded particles, with or without added agglutination enhancing reagents (e.g., LISS, enzymes), presented as a a set of gels or solid phase columns and intended to be used in testing a clinical specimen for red blood cell antigens and/or antibodies, using a column agglutination technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750006007	GS1

Storage Conditions

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