Chemcard Glucose

GUDID 00737051736922

The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived

CHEMATICS, INC.

Glucose IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00737051736922
• NIH Device Record Key: 1e9f85e4-81dd-4dbb-9781-1df1d861f9ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemcard Glucose
• Version Model Number: 47000
• 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	00737051736908 [Primary]
GS1	00737051736915 [Package]; Contains: 00737051736908; Package: Box [24 Units]; In Commercial Distribution
GS1	00737051736922 [Package]; Contains: 00737051736915; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943503

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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

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• 00737051736922 - Chemcard Glucose: 2018-07-06The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived
• 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