Pointe Methadone Level 1 Control (225 ng/mL)

Basic Information

• Brand Name: Pointe Methadone Level 1 Control (225 ng/mL)
• Primary DI: 00811727017086
• Version / Model: 60-ME0234-5
• Catalog Number: 60-ME0234-5
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 0d76019e-4af9-4382-b881-2d98a51eb638

Device Description

Pointe Methadone Level 1 Control (225 ng/mL) 1 x 5 mL The Pointe Methadone Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methadone Reagent Set (Ref# 60-ME0220-100/60-ME0220-1L) on a number of automated clinical chemistry analyzers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49988	Human astrovirus nucleic acid IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from human astrovirus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727017086	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K023316	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius