Lipase NG OC Cal 04Y85-01

GUDID 08058056682291

Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.

SENTINEL CH. SPA

Lipase IVD, calibrator

• Primary Device ID: 08058056682291
• NIH Device Record Key: bc01996a-853c-484c-8e7a-dfb4c70e7900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lipase NG OC Cal
• Version Model Number: 04Y85-01
• Catalog Number: 04Y85-01
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056682291 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2019-04-24
• Device Publish Date: 2019-04-16

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