Pointe Scientific, Inc. Magnesium OM929-300

GUDID 00811727015099

Pointe Scientific, Inc. Magnesium Reagent is for the quantitative determination of magnesium in serum. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 6 x 25ml, 6 x 25ml

POINTE SCIENTIFIC, INC.

Magnesium (Mg2+) IVD, reagent

• Primary Device ID: 00811727015099
• NIH Device Record Key: 6cb24a81-4ae0-4f79-8530-af0a95576df7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific, Inc. Magnesium
• Version Model Number: OM929-300
• Catalog Number: OM929-300
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727015099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853592

FDA Product Code

• JGJ: Photometric Method, Magnesium

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, Inc. Magnesium]

• 00811727015099: Pointe Scientific, Inc. Magnesium Reagent is for the quantitative determination of magnesium in
• 00811727014801: Pointe Magnesium is for the quantitative determination of magnesium in serum. For in vitro diagn
• 00811727014795: Pointe Magnesium Reagent is for the quantitative determination of magnesium in serum. For in vit
• 00811727014788: Pointe Magnesium Reagent is for the quantitative determination of magnesium in serum. For in vit
• 00811727013088: Magnesium Reagent is for the quantitative determination of magnesium in serum. For in vitro diag