Pointe Scientific HB952-654

GUDID 00811727012951

BUN reagent for the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Urea IVD, reagent

• Primary Device ID: 00811727012951
• NIH Device Record Key: ec68d86d-a9b9-4c2f-8e1b-886a86c62534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific
• Version Model Number: HB952-654
• Catalog Number: HB952-654
• 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: 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: 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	00811727012951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972671

FDA Product Code

• CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

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: 2018-07-06
• Device Publish Date: 2016-08-31

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