Albumin (w/ssa#) 13-A7502-120

GUDID 00811727013682

For the quantitative determination of Albumin in serum.

POINTE SCIENTIFIC, INC.

Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry Albumin IVD, kit, spectrophotometry

• Primary Device ID: 00811727013682
• NIH Device Record Key: 89c356bd-753b-4378-81fe-3f45ca6d1279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Albumin (w/ssa#)
• Version Model Number: 13-A7502-120
• Catalog Number: 13-A7502-120
• 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	00811727013682 [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 [Albumin (w/ssa#)]

• 00811727013699: For the quantitative determination of Albumin in serum.
• 00811727013682: For the quantitative determination of Albumin in serum.