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, Diagnostic Products Corp. and Diagnostic Systems Laboratories, Inc..
86
Total
86
Cleared
95d
Avg days
1977
Since
86 devices
Cleared
Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
Diagnostic Products Corp.
Chemistry
14d
Cleared
Oct 31, 1997
ACTIVE INTACT PTH
Diagnostic Systems Laboratories, Inc.
Chemistry
44d
Cleared
Dec 10, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
Nichols Institute Diagnostics
Chemistry
161d
Cleared
Sep 27, 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
Nichols Institute Diagnostics
Chemistry
126d
Cleared
Nov 03, 1995
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
Nichols Institute Diagnostics
Chemistry
42d
Cleared
Jul 17, 1995
ACTIVE INTACT PTH ELISA
Diagnostic Systems Laboratories, Inc.
Chemistry
68d
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
Bio-Rad
Chemistry
128d
Cleared
May 14, 1992
N-TACT(R) PTH SP KIT
Incstar Corp.
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)
Incstar Corp.
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)
Incstar Corp.
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
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 30, 1982
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
Travenol Laboratories, S.A.
Chemistry
87d
Cleared
Dec 03, 1981
C-TERMINAL PTH RIA TEST KIT, DSL-1000
Diagnostic Systems Laboratories, Inc.
Chemistry
20d