Bilirubin Standard Kit

GUDID 00852553007063

Calibrator / Calibration Verifier

VERICHEM LABORATORIES, INC.

Conjugated (direct) bilirubin IVD, calibrator

• Primary Device ID: 00852553007063
• NIH Device Record Key: e265a277-4d4c-467c-bd30-a8296fb23d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilirubin Standard Kit
• Version Model Number: 9450
• Company DUNS: 189023351
• Company Name: VERICHEM LABORATORIES, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-552-5859
• Email: customerservice@verichemlabs.com

Device Dimensions

• Total Volume: 50 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852553007063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882059

FDA Product Code

• JIT: Calibrator, Secondary

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: 2016-11-29

Devices Manufactured by VERICHEM LABORATORIES, INC.

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• 00852553007025 - HDL Cholesterol Verifier Kit: 2018-07-06
• 00852553007032 - Urine Uric Acid Standard Kit: 2018-07-06 calibrator / calibration verifier
• 00852553007049 - Enzymer Verifier Kit: 2018-07-06 Calibration Verifier
• 00852553007056 - Enzymer ER Verifier Kit: 2018-07-06 Calibration Verifier
• 00852553007063 - Bilirubin Standard Kit: 2018-07-06Calibrator / Calibration Verifier
• 00852553007063 - Bilirubin Standard Kit: 2018-07-06 Calibrator / Calibration Verifier
• 00852553007070 - Bilirubin Standard, Level F: 2018-07-06 Calibrator / Calibration Verifier