Pointe Scientific, Inc. Phosphorus OP916-576

GUDID 00811727015105

Pointe Scientific, Inc. Phosphorus Reagent is for the quantitative determination of inorganic phosphorus in serum on Olympus analyzers. For in vitro diagnostic use only. 6 x 66ml, 6 x 30ml

POINTE SCIENTIFIC, INC.

Inorganic phosphate (PO43-) IVD, reagent

• Primary Device ID: 00811727015105
• NIH Device Record Key: 0ffc1dbd-b04e-437a-9e14-690a9b595a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific, Inc. Phosphorus
• Version Model Number: OP916-576
• Catalog Number: OP916-576
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727015105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822470

FDA Product Code

• CEO: Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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. Phosphorus]

• 00811727015105: Pointe Scientific, Inc. Phosphorus Reagent is for the quantitative determination of inorganic ph
• 00811727014818: Pointe Phosphorus is for the quantitative determination of inorganic phosphorus in serum on Hita
• 00811727013095: Phosphorus Reagent is for the quantitative determination of inorganic phosphorus in serum on Hit
• 00811727011961: Pointe Scientific, Inc. Phosphorus Reagent for the quantitative determination of Inorganic Phosp
• 00811727011954: Pointe Scientific, Inc. Phosphorus Reagent for the quantitative determination of Inorganic Phosp
• 00811727011947: Pointe Scientific, Inc. Phosphorus Reagent for the quantitative determination of Inorganic Phosp