ClearChem Diagnostics Inc. Bilirubin, Direct BRD1050

GUDID 00852169008096

In Vitro Diagnostics testing kit R1:3X28mL, R2:3X7mL

CLEARCHEM DIAGNOSTICS INC.

Conjugated (direct) bilirubin IVD, reagent

• Primary Device ID: 00852169008096
• NIH Device Record Key: fbc9246e-a1c0-4c26-a7aa-38b07a5f1fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChem Diagnostics Inc. Bilirubin, Direct
• Version Model Number: BRD1050
• Catalog Number: BRD1050
• Company DUNS: 010655581
• Company Name: CLEARCHEM DIAGNOSTICS INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)734-8041
• Email: dwheat@clearchem.net

Device Dimensions

• Total Volume: 105 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852169008096 [Primary]

FDA Product Code

• CIG: DIAZO COLORIMETRY, BILIRUBIN

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: 2018-05-31
• Device Publish Date: 2018-04-30

Devices Manufactured by CLEARCHEM DIAGNOSTICS INC.

• 00852169008201 - ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol: 2020-05-12 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
• 00852169008294 - ClearChem Diagnostics Inc. MicroProtein, Total: 2018-07-09 In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL
• 00852169008232 - ClearChem Diagnostics Inc. TIBC-Direct: 2018-06-22 In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL
• 00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin: 2018-06-22 In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
• 00852169008287 - ClearChem Diagnostics Inc. Hemoglobin A-1c: 2018-06-22 In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL
• 00852169008058 - ClearChem Diagnostics Inc. Aspartate aminotransferase (AST): 2018-06-18 In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
• 00852169008164 - ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol: 2018-06-18 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
• 00852169008072 - ClearChem Diagnostics Inc. Carbon Dioxide (CO2): 2018-06-11 In Vitro Diagnostics testing kit R1:6X30mL