Pointe Buprenorphine Reagent Set 60-BP0540-1L

GUDID 00811727016317

Pointe Buprenorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Buprenorphine Reagent Set is intended for the qualitative and semi-quantitative determination of norbuprenorphine (a buprenorphine metabolite) in human urine at a cutoff value of 5 ng/mL and 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

POINTE SCIENTIFIC, INC.

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00811727016317
• NIH Device Record Key: c279b5fb-5d35-4788-9002-71f6d4bb6e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Buprenorphine Reagent Set
• Version Model Number: 60-BP0540-1L
• Catalog Number: 60-BP0540-1L
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727016317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090844

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Pointe Buprenorphine Reagent Set]

• 00811727016317: Pointe Buprenorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Buprenorphine Reagent
• 00811727016300: Pointe Buprenorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Buprenorphine Reagent