Glucose GOD-PAP Trinder Method Test Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791066 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Fermco Biochemics, Inc. →

• What is the Glucose GOD-PAP Trinder Method Test Kit used for?

  The test kit is used to measure glucose quantitatively in blood and other body fluids. These measurements help in diagnosing and treating carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, as well as pancreatic islet cell carcinoma.

• Is the Glucose GOD-PAP Trinder Method Test Kit a single-use device?

  Yes, the test kit is manufactured as a single-use device. This means it is designed for one-time use only and should not be reused or repurposed after initial use to ensure accurate test results and maintain safety standards.

• What is the regulatory status of the Glucose GOD-PAP Trinder Method Test Kit?

  The device is regulated under FDA 510(k) clearance with product code CGA and authorization number K791066. It was received on June 12, 1979, and cleared on September 4, 1979. It is classified under Clinical Chemistry and is not indicated for MRI use.

• How is the Glucose GOD-PAP Trinder Method Test Kit supplied?

  The test kit is supplied as a complete kit containing all necessary components for glucose measurement. It is manufactured by Fermco Biochemics, Inc. and is designed for single-use in clinical laboratory settings to ensure accurate and reliable glucose testing results.