Validate 301db

GUDID 00859110005036

Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments.

MAINE STANDARDS COMPANY, LLC

Multiple therapeutic drugs/drugs of abuse IVD, control

• Primary Device ID: 00859110005036
• NIH Device Record Key: f9371457-fbd2-4776-b694-5a824eb67626
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Validate
• Version Model Number: 301db
• Catalog Number: 301db
• Company DUNS: 075886031
• Company Name: MAINE STANDARDS COMPANY, LLC
• 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: true
• 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: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com
• Phone: 1-800-377-9684
• Email: info@mainestandards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859110005036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033879

FDA Product Code

• DKB: Calibrators, Drug Mixture

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: 2016-09-23

On-Brand Devices [Validate]

• 00859110005265: Validate GC1sv is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005258: Validate GC1vt is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005241: Validate GC1sa is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005234: Validate GC1sd is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005227: Validate GC1ri is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005210: Validate GC1ro is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005203: Validate GC1bc is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005197: Validate GC1au is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005180: Validate GC1ab is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005142: Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
• 00859110005135: Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
• 00859110005128: Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
• 00859110005111: Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
• 00859110005104: Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
• 00859110005098: Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
• 00859110005081: Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
• 00859110005074: Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
• 00859110005067: Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
• 00859110005050: Validate TDM1vt is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005043: Validate TDM1ri is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005036: Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005029: Validate TDM1bc is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005012: Validate TDM1au is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005005: Validate TDM1ab is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005418: Validate GC4 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005968: Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005876: Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005838: Validate Vit D is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005814: Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/
• 00859110005746: Validate LP is intended for the quantitative determination of Calibration Verification/Linearity
• 00859110005630: Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005593: Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005579: Validate Anemia is intended for the quantitative determination of Calibration Verification/Linea
• 00859110005548: Validate Body Fluids is intended for the quantitative determination of Calibration Verification/
• 00859110005517: Validate IBC is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005340: Validate GC3 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005289: Validate GC2 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005272: Validate GC2 is intended for the quantitative determination of Calibration Verification/Linearit
• 00850011135174: Validate THY is intended for the quantitative determination of Calibration Verification/Linearit
• 00850011135105: Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearit
• 00850011135044: Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005999: Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005982: Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005975: Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005951: Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration
• 00859110005944: Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005937: Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linear
• 00859110005920: Validate SP3 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005913: Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearit
• 00859110005906: Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearit