Validate 904il

GUDID 00859110005128

Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/Linearity of fibrinogen on automated instruments.

MAINE STANDARDS COMPANY, LLC

Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control Fibrinogen assay (factor I) IVD, control

• Primary Device ID: 00859110005128
• NIH Device Record Key: 0312b462-e48b-475b-aa84-dab2d0758ed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Validate
• Version Model Number: 904il
• Catalog Number: 904il
• Company DUNS: 075886031
• Company Name: MAINE STANDARDS COMPANY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com
• Phone: 1-800-377-9684
• Email: msc.info@lgcgroup.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859110005128 [Primary]

FDA Product Code

• GIL: Plasma, Fibrinogen Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-18

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