Pointe Opiates 300 Reagent Set 60-OP0040-1L

GUDID 00811727016874

Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only.

POINTE SCIENTIFIC, INC.

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00811727016874
• NIH Device Record Key: 27df7560-3146-4682-bb98-42886a4ea9f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Opiates 300 Reagent Set
• Version Model Number: 60-OP0040-1L
• Catalog Number: 60-OP0040-1L
• 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	00811727016874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110298

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 Opiates 300 Reagent Set]

• 00811727016874: Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set
• 00811727016867: Pointe Opiates 300 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Opiates 300 Reagent Set