CEW · Class II · 21 CFR 862.1545

FDA Product Code CEW: Radioimmunoassay, Parathyroid Hormone

Parathyroid hormone measurement is essential in the management of calcium disorders. FDA product code CEW covers radioimmunoassay systems for parathyroid hormone quantification.

These assays measure PTH levels in serum for the diagnosis and monitoring of hyperparathyroidism, hypoparathyroidism, and metabolic bone disease. Intraoperative PTH monitoring is used to confirm successful parathyroid adenoma removal during parathyroidectomy.

CEW devices are Class II medical devices, regulated under 21 CFR 862.1545 and reviewed by the FDA Immunology panel.

Leading manufacturers include Nichols Institute Diagnostics, Scantibodies Laboratory, Inc. and Diagnostic Products Corp..

86

Total

86

Cleared

95d

Avg days

1977

Since

86 devices

49–72 of 86

Cleared Apr 13, 1995

Chemistry · 84d

Cleared Sep 20, 1994

GAMMA-BCT INTACT PTH

Immunodiagnostic Systems , Ltd.

Chemistry · 125d

Cleared Sep 07, 1994

OCTEIA INTACT PTH

Chemistry · 142d

Cleared Dec 10, 1993

IMMUNLITE INTACT PTH

Diagnostic Products Corp.

Chemistry · 67d

Cleared Jun 15, 1993

COAT-A-COUNT INTACT PTH IRMA

Diagnostic Products Corp.

Chemistry · 162d

Cleared Sep 02, 1992

COTUBE PTH IRMA

Chemistry · 128d

Cleared May 14, 1992

N-TACT(R) PTH SP KIT

Chemistry · 38d

Cleared Oct 25, 1991

VENTREX COATED TUBE INTACT PTH

Ventrex Laboratories, Inc.

Chemistry · 85d

Cleared Sep 25, 1990

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY

London Diagnostics, Inc.

Chemistry · 70d

Cleared Jul 16, 1990

PTH-MM II 125I RADIOIMMUNOASSAY (RIA)

Chemistry · 94d

Cleared Nov 21, 1989

DSL I-PTH (DSL #8000)

Diagnostic Systems Laboratories, Inc.

Chemistry · 21d

Cleared Oct 13, 1988

CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY

Ciba Corning Diagnostics Corp.

Chemistry · 114d

Cleared Nov 23, 1987

N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)

Chemistry · 34d

Cleared Sep 25, 1987

DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2

Diagnostic Products Corp.

Chemistry · 127d

Cleared Jul 22, 1986

ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY

Nichols Institute Diagnostics

Chemistry · 74d

Cleared Oct 04, 1985

C-TERMINAL PTH RIA KIT

Diagnostic Systems Laboratories, Inc.

Chemistry · 25d

Cleared Apr 29, 1985

Syncor Intl. Corp.

Chemistry · 146d

Cleared Apr 03, 1985

PARATHYROID HORMONE RADIOIMMUNOASSAY KIT

Cambridge Medical Technology

Chemistry · 71d

Cleared Oct 30, 1984

PARATHYROID HORMONE MID-MOLECULE RIA-KIT

Diagnostic Products Corp.

Chemistry · 28d

Cleared Oct 30, 1984

PARATHYROID HORMONE C-TERMINAL RIA KIT

Diagnostic Products Corp.

Chemistry · 28d

Cleared Oct 11, 1984

C-TERMINAL/MID-MOLECULE PARATHYROID -

Nichols Institute Diagnostics

Chemistry · 23d

Cleared Apr 04, 1984

PARATHYROID HORMONE ANALYSIS PRODUCT

Nichols Institute Diagnostics

Chemistry · 68d

Cleared Dec 29, 1983

C. PTH RADIOIMMUNOASSAY KIT-CPTHK

Sorin Biomedica, Fiat, USA, Inc.

Chemistry · 63d

Cleared Jun 22, 1983

Ramco Laboratories, Inc.

Chemistry · 47d