DADE RPR Card Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811152 ↗

FDA Product Code

GMQ

Device Class

Class II

Regulation

21 CFR Part 866.3820

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the DADE RPR Card Test used for?

  The DADE RPR Card Test is an in vitro diagnostic device that uses nontreponemal antigens to detect antibodies associated with syphilis infection. It provides a qualitative result for the screening of treponemal disease in clinical laboratory settings.

• How is the DADE RPR Card Test supplied and can it be reused?

  The device is supplied as a test kit and is intended for single-use only. It should not be reused and should be used according to the manufacturer's instructions in clinical laboratory settings.

• What are the storage requirements for the DADE RPR Card Test?

  The DADE RPR Card Test should be stored according to the manufacturer's instructions. It is important to note that this device is not MRI safe, so proper storage conditions must be maintained to ensure test integrity.

• What is the regulatory status of the DADE RPR Card Test?

  The DADE RPR Card Test has received FDA 510(k) clearance with a device class of 2 and product code GMQ. It is substantially equivalent to other devices in its class and is intended for the screening of treponemal disease.