Lipase NG OC CTRL 1 04Y85-10

GUDID 08058056682307

Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG. Use the Control Material like the specimens, according to the indicated analytical procedure.

SENTINEL CH. SPA

Lipase IVD, control

• Primary Device ID: 08058056682307
• NIH Device Record Key: f7d4095a-cb46-462b-8339-fc3b2488ced9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lipase NG OC CTRL 1
• Version Model Number: 04Y85-10
• Catalog Number: 04Y85-10
• 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	08058056682307 [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: 2019-04-24
• Device Publish Date: 2019-04-16

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