VALIDATE

GUDID 00850011135563

Validate LCMS Steroids Test Kit

Lgc Clinical Diagnostics, Inc.

Free testosterone IVD, control

• Primary Device ID: 00850011135563
• NIH Device Record Key: b4b3512a-4e8e-4f46-a7fb-76d52e391f98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALIDATE
• Version Model Number: 1003ro
• Company DUNS: 075886031
• Company Name: Lgc Clinical Diagnostics, Inc.
• 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: 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: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011135563 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [VALIDATE]

• 00850011135235: Validate Anemia is intended for the quantitative determination of Calibration Verification/Linea
• 00850011135228: Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearit
• 00850011135211: Validate ACTH is intended for the quantitative determination of Calibration Verification/Lineari
• 00850011135471: Validate 1300wa is intended for Calibration Verification/Linearity of general chemistries on aut
• 00850011135464: Validate 1100wa is intended for Calibration Verification/Linearity of general chemistries on aut
• 00850011135457: Validate VIT D Single clinical chemistry analyte IVD, control
• 00850011135396: Validate ISX Multiple-type clinical chemistry analyte IVD, control
• 00850011135495: aHBs Calibration Verification / Linearity Test kit
• 00850011135518: Rubella IgG Calibration Verification / Linearity Test Kit
• 00850011135525: Validate UC1 is intended for the determination of Calibration Verification/Linearity on automate
• 00850011135549: Toxoplasma IgG Calibration Verification / Linearity Test Kit
• 00850011135594: Anti-CCP Calibration Verification / Linearity Test Kit
• 00850011135624: VALIDATE OCN Calibration Verification / Linearity Test Kit solutions are intended for in vitro d
• 00850011135631: VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro d
• 00850011135617: VALIDATE Folate RBC Calibration Verification / Linearity Test Kit solutions are intended for in
• 00850011135662: VALIDATE B-CTx Calibration Verification/Linearity Test Kit
• 00850011135648: VALIDATE CT Calibration Verification/Linearity Test Kit
• 00850011135679: VALIDATE Fertility 4 Calibration Verification/Linearity Test Kit
• 00850011135723: Validate THY Calibration Verification / Linearity Test Kit solutions are intended for in vitro d
• 00850011135730: Validate LCMS VIT D Test Kit
• 00850011135761: VALIDATE MTX Calibration Verification / Linearity Test Kit
• 00850011135808: Growth Hormone 2 Calibration Verification / Linearity Test Kit
• 00850011135563: Validate LCMS Steroids Test Kit