InteliQ 12008299

GUDID 03610522046140

InteliQ Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.)

BIO-RAD LABORATORIES, INC.

Ethanol (ETOH) IVD, control

• Primary Device ID: 03610522046140
• NIH Device Record Key: 603bcd2c-a450-4ea7-bb92-3eed2bac3d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InteliQ
• Version Model Number: 12008299
• Catalog Number: 12008299
• Company DUNS: 051624070
• Company Name: BIO-RAD LABORATORIES, 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610522046140 [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: 2020-09-22
• Device Publish Date: 2020-09-14

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• 03610522114429: InteliQ Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers
• 03610522114412: InteliQ Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers
• 03610522114405: InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers c
• 03610522114399: InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers c
• 03610522114382: InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers c
• 03610522114375: InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.
• 03610522114368: InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.
• 03610522114351: InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.
• 03610522114344: InteliQ Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
• 03610522114337: InteliQ Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
• 03610522114320: InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
• 03610522113873: InteliQ Immunology Control MiniPak (A human serum assayed protein control.)
• 03610522113866: InteliQ Immunology Control Level 3 (A human serum assayed protein control.)
• 03610522113859: InteliQ Immunology Control Level 2 (A human serum assayed protein control.)
• 03610522113842: InteliQ Immunology Control Level 1 (A human serum assayed protein control.)
• 03610522046171: InteliQ Ethanol/Ammonia Control MiniPak (An assayed ethanol and ammonia control.)
• 03610522046164: InteliQ Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.)
• 03610522046157: InteliQ Ethanol/Ammonia Control Level 2 (An assayed ethanol and ammonia control.)
• 03610522046140: InteliQ Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.)
• 03610522046072: InteliQ Tumor Marker Control MiniPak (A human based assayed tumor marker control.)
• 03610522046065: InteliQ Tumor Marker Control Level 3 (A human based assayed tumor marker control.)
• 03610522046058: InteliQ Tumor Marker Control Level 2 (A human based assayed tumor marker control.)
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• 03610522045952: InteliQ Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)
• 03610522045945: InteliQ Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
• 03610522045938: InteliQ Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)
• 03610522045921: InteliQ Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)
• 03610522045914: InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.)
• 03610522045846: InteliQ Assayed Multiqual Control MiniPak (A human serum assayed chemistry control.)
• 03610522045839: InteliQ Assayed Multiqual Control Level 3 (A human serum assayed chemistry control.)
• 03610522045822: InteliQ Assayed Multiqual Control Level 2 (A human serum assayed chemistry control.)
• 03610522045815: InteliQ Assayed Multiqual Control Level 1 (A human serum assayed chemistry control.)
• 03610520267233: InteliQ Homocysteine Control MiniPak (A human serum assayed homocysteine control.)
• 03610520267226: InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.)
• 03610520267219: InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.)
• 03610520242582: InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.)
• 03610522115969: InteliQ Urine Chemistry Control Level 2 (A human urine assayed chemistry control.)
• 03610522115952: InteliQ Urine Chemistry Control Level 1 (A human urine assayed chemistry control.)
• 03610522115945: InteliQ Urine Chemistry Control Bilevel MiniPak (A human urine assayed chemistry control.)
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• 03610522046270: InteliQ Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
• 03610522046263: InteliQ Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
• 03610522046256: InteliQ Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
• 03610522046249: InteliQ Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
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