ClearChem Diagnostics Inc. MicroAlbumin MAL1010

GUDID 00852169008270

In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL

CLEARCHEM DIAGNOSTICS INC.

Microalbumin IVD, reagent

• Primary Device ID: 00852169008270
• NIH Device Record Key: 30e60822-e009-47d8-b037-2b8c2c16aea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChem Diagnostics Inc. MicroAlbumin
• Version Model Number: MAL1010
• Catalog Number: MAL1010
• 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: 100 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *Keep Refrigerated

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852169008270 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

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: 2018-06-22
• Device Publish Date: 2018-05-22

Devices Manufactured by CLEARCHEM DIAGNOSTICS INC.

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• 00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin: 2018-06-22In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
• 00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin: 2018-06-22 In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
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• 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