Clin Chem Cal 16550

GUDID 08058056680136

Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.

SENTINEL CH. SPA

Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 08058056680136
• NIH Device Record Key: 7c8d669a-3d83-4b1c-8899-039fef150ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clin Chem Cal
• Version Model Number: 16550
• Catalog Number: 16550
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it
• Phone: 9999999999
• Email: customerservice@sentinel.it

Device Dimensions

• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter
• Total Volume: 12 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056680136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070971

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2020-12-21
• Device Publish Date: 2016-06-29

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