Pointe Phosphorus Reagent 14-P7516-174

GUDID 00811727015945

Pointe Phosphorus Reagent packaged for use on the Mindray BS480. 3 x 58ml. For the quantitative determination of Inorganic Phosphorus in serum.

POINTE SCIENTIFIC, INC.

Inorganic phosphate (PO43-) IVD, reagent

• Primary Device ID: 00811727015945
• NIH Device Record Key: 049a0be6-9481-42bb-8cd7-2179b2a383cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Phosphorus Reagent
• Version Model Number: 14-P7516-174
• Catalog Number: 14-P7516-174
• 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@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727015945 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-08
• Device Publish Date: 2021-01-30

On-Brand Devices [Pointe Phosphorus Reagent]

• 00811727016249: Pointe Phosphorus Reagent packaged for use on the Mindray BA800. 2 x 66ml R1, 2 x 30ml R2. For
• 00811727015945: Pointe Phosphorus Reagent packaged for use on the Mindray BS480. 3 x 58ml. For the quantitative