MTS MTS085014

GUDID 10758750006007

MTS Buffered Gel Card

MICRO TYPING SYSTEMS, INC

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