ClearChem Diagnostics Inc. Creatinine (Jaffe) CRE1120

GUDID 00852169008126

In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL

CLEARCHEM DIAGNOSTICS INC.

Creatinine IVD, reagent

• Primary Device ID: 00852169008126
• NIH Device Record Key: 8805e3c4-b237-404e-8e19-c5c15fc6de29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChem Diagnostics Inc. Creatinine (Jaffe)
• Version Model Number: CRE1120
• Catalog Number: CRE1120
• 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: 180 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	00852169008126 [Primary]

FDA Product Code

• CGX: ALKALINE PICRATE, COLORIMETRY, CREATININE

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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