Pointe Scientific HH945-480

GUDID 00811727012913

HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml

POINTE SCIENTIFIC, INC.

High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent

• Primary Device ID: 00811727012913
• NIH Device Record Key: d0b2b3e8-b178-4427-9301-b8fea539beb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific
• Version Model Number: HH945-480
• Catalog Number: HH945-480
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, INC.
• 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: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727012913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992002

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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