Fiax Test Kit for ENA (RNP/SM) Antibodies

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

510(k) Number

K873708 ↗

FDA Product Code

LLL

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Whittaker Bioproducts, Inc. →

• What is the Fiax Test Kit for ENA (RNP/SM) Antibodies used for?

  The Fiax Test Kit is an immunology testing device used to detect antibodies against extractable nuclear antigens, specifically RNP and SM antibodies, which are associated with autoimmune conditions.

• Is the Fiax Test Kit for ENA (RNP/SM) Antibodies a single-use device?

  Yes, the Fiax Test Kit is supplied as a single-use device and is not MRI compatible. It is designed for one-time use in clinical laboratories.

• What regulatory approvals does the Fiax Test Kit for ENA (RNP/SM) Antibodies have?

  The Fiax Test Kit has FDA 510(k) clearance with the product code LLL. It is manufactured by Whittaker Bioproducts, Inc. and is authorized for use in clinical laboratories.

• How should the Fiax Test Kit for ENA (RNP/SM) Antibodies be stored?

  The device should be stored according to the manufacturer's instructions, which are provided with the test kit.