MTS MTS085014

GUDID 10758750006007

MTS Buffered Gel Card

MICRO TYPING SYSTEMS, INC

Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD Column agglutination IVD

• Primary Device ID: 10758750006007
• NIH Device Record Key: 88b0c2e0-4dd4-4625-9208-09cbb18e9e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTS
• Version Model Number: MTS085014
• Catalog Number: MTS085014
• Company DUNS: 781421888
• Company Name: MICRO TYPING SYSTEMS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750006007 [Primary]

FDA Product Code

• KSZ: SYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-21
• Device Publish Date: 2016-08-24

On-Brand Devices [MTS]

• 10758750005901: MTS Anti-E (Monoclonal) Card
• 10758750006045: MTS Diluent 2 Plus
• 10758750006038: MTS Diluent 2
• 10758750006106: MTS™ Worktable (plastic rack to hold cards and samples)
• 10758750006090: ID-TIPMASTER
• 10758750006069: MTS DISPENSER 1.0ML
• 10758750006052: MTS DISPENSER 0.5ML
• 10758750006007: MTS Buffered Gel Card
• 10758750005949: MTS Monoclonal Control Card
• 10758750006113: MTS™ Incubator
• 10758750005802: MTS™ Centrifuge model 5150-60