Chemcard Cholesterol

GUDID 00737051548327

The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.

CHEMATICS, INC.

Multiple lipid analyte IVD, kit, colorimetric, rapid

• Primary Device ID: 00737051548327
• NIH Device Record Key: b4b86a7b-00d8-42ef-9c85-2deee67e0390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemcard Cholesterol
• Version Model Number: 43001
• Company DUNS: 196929947
• Company Name: CHEMATICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00737051548303 [Primary]
GS1	00737051548310 [Package]; Contains: 00737051548303; Package: Box [24 Units]; In Commercial Distribution
GS1	00737051548327 [Package]; Contains: 00737051548310; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864159

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

Devices Manufactured by CHEMATICS, INC.

• 00737051548327 - Chemcard Cholesterol: 2018-07-06The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk of coronary artery disease. 510K Cleared for Professional Use Only.
• 00737051548327 - Chemcard Cholesterol: 2018-07-06 The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify el
• 00737051654806 - Alco-Screen: 2018-07-06 ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The
• 00737051736922 - Chemcard Glucose: 2018-07-06 The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma
• 00737051863109 - Alco-Screen02: 2018-07-06 ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects rel