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 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 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 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 16, 1983

DAC-CEL PTH KIT RD51

Wellcome Diagnostics

Chemistry · 73d

Cleared May 09, 1983

HUMAN INTRACT PARATHYROID HORMONE BY

Immuno Nuclear Corp.

Chemistry · 67d

Cleared Dec 30, 1982

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT

Travenol Laboratories, S.A.

Chemistry · 87d

Cleared Mar 11, 1982

MIN-MOLECULE PTH BY RADIOIMMUNOASSAY

Immuno Nuclear Corp.

Chemistry · 43d

Cleared Dec 03, 1981

C-TERMINAL PTH RIA TEST KIT, DSL-1000

Diagnostic Systems Laboratories, Inc.

Chemistry · 20d

Cleared Jun 25, 1981

C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT

Immuno Nuclear Corp.

Chemistry · 21d

Cleared Jun 24, 1981

N-TERMINAL HPTH BY RIA

Immuno Nuclear Corp.

Chemistry · 36d