POINTE SCIENTIFIC ALBUMIN 12-A7502-160

GUDID 00811727013385

For the quantitative determination of Albumin in serum.

POINTE SCIENTIFIC, INC.

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• Primary Device ID: 00811727013385
• NIH Device Record Key: ba1c63ee-0a05-40de-8773-fe9dfd6fc696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POINTE SCIENTIFIC ALBUMIN
• Version Model Number: 12-A7502-160
• Catalog Number: 12-A7502-160
• 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
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727013385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822471

FDA Product Code

• CIX: Bromcresol Green Dye-Binding, Albumin

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

On-Brand Devices [POINTE SCIENTIFIC ALBUMIN]

• 00811727013385: For the quantitative determination of Albumin in serum.
• 00811727010032: For the quantitative determination of Albumin in serum.
• 00811727010025: For the quantitative determination of Albumin in serum.
• 00811727010018: For the quantitative determination of Albumin in serum.