ClearChem Diagnostics Inc. Creatine Kinase (CK) CPK1110

GUDID 00852169008089

In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

CLEARCHEM DIAGNOSTICS INC.

Total creatine kinase (CK) IVD, reagent

• Primary Device ID: 00852169008089
• NIH Device Record Key: cbc2a7e9-2802-4757-93ec-38f70eb09a5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChem Diagnostics Inc. Creatine Kinase (CK)
• Version Model Number: CPK1110
• Catalog Number: CPK1110
• 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: 225 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	00852169008089 [Primary]

FDA Product Code

• CGS: NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

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

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