TruePoint 64200

GUDID 00193169642003

TruePoint Control Solution Low 4mL

OK BIOTECH CO., LTD.

Glucose IVD, control

• Primary Device ID: 00193169642003
• NIH Device Record Key: 192cb757-8dcf-4468-8da2-655b8945da9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruePoint
• Version Model Number: 64200
• Catalog Number: 64200
• Company DUNS: 658796458
• Company Name: OK BIOTECH CO., LTD.
• 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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193169642003 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-13
• Device Publish Date: 2025-06-05

On-Brand Devices [TruePoint]

• 00193169642409: Blood Glucose Test Strips
• 00193169642362: Blood Glucose Test Strips
• 00193169642348: Blood Glucose Test Strips
• 00193169642331: Blood Glucose Test Strips
• 00193169642324: Blood Glucose Test Strips
• 10193169642307: Blood Glucose Test Strips
• 00193169642003: TruePoint Control Solution Low 4mL