Thrombo-TIC 1:100 pur

GUDID 04061609000194

BIOANALYTIC GmbH, biomed. Analysentechnik

Platelet count IVD, reagent

• Primary Device ID: 04061609000194
• NIH Device Record Key: dbb043b6-ebe2-4f70-a4af-71de6128d9dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thrombo-TIC 1:100 pur
• Version Model Number: 004015-0006
• Company DUNS: 327536728
• Company Name: BIOANALYTIC GmbH, biomed. Analysentechnik
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04061609000194 [Primary]
GS1	04061609000606 [Unit of Use]

FDA Product Code

• JCG: Fluid, Diluting, Manual Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-06

On-Brand Devices [Thrombo-TIC 1:100 pur]

• 04061609000699: 004015-6011DMD
• 04061609000231: 004015-6010
• 04061609000194: 004015-0006