POINTE SCIENTIFIC Calcium Arsenazo C7529-120

GUDID 00811727010629

For the quantitative determination of Calcium in serum or heparinized plasma.

POINTE SCIENTIFIC, INC.

Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry Calcium (Ca2+) IVD, kit, spectrophotometry

• Primary Device ID: 00811727010629
• NIH Device Record Key: a125722f-c82a-4b11-a55e-9cc8d193f5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POINTE SCIENTIFIC Calcium Arsenazo
• Version Model Number: C7529-120
• Catalog Number: C7529-120
• 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
• 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
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727010629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921625

FDA Product Code

• CIC: Cresolphthalein Complexone, Calcium

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 Calcium Arsenazo]

• 00811727010643: For the quantitative determination of Calcium in serum or heparinized plasma.
• 00811727010636: For the quantitative determination of Calcium in serum or heparinized plasma.
• 00811727010629: For the quantitative determination of Calcium in serum or heparinized plasma.