Radioimmunoassay, Parathyroid Hormone
FDA product code CEW · 84 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1545
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-10-14 – 2024-03-22
CEW
2024-03-22
CEW
2024-03-01
Access Intact PTH
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CEW
2023-09-05
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
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CEW
2019-08-30
Lumipulse G whole PTH
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CEW
2017-05-23
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
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CEW
2017-01-31
IDS-iSYS Intact PTHN
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CEW
2013-11-08
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
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CEW
2013-03-21
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
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CEW
2012-02-03
IDS-ISYS INTACT PTH
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CEW
2010-10-22
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
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CEW
2007-07-13
ROCHE ELECSYS PTH TEST SYSTEM
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CEW
2007-06-21
ST AIA-PACK INTACT PTH ASSAY
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CEW
2007-06-19
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
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CEW
2007-03-20
ELECSYS PTH TEST SYSTEM
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CEW
2006-09-15
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
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CEW
2006-03-01
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
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CEW
2006-02-27
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
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CEW
2006-02-03
IMMULITE/IMMULITE 1000 TURBO INTACT PTH
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CEW
2005-10-18
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
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CEW
2005-09-09
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
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CEW
2005-07-26
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
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CEW
2005-07-26
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
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CEW
2004-06-08
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
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CEW
2004-04-22
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
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CEW
2004-02-12
LIAISON N-TACT PTH
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CEW
2004-01-26
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
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CEW
2003-07-30
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
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CEW
2002-10-09
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
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CEW
2002-08-21
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
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CEW
2002-05-31
AXSYM INTACT PTH, MODEL 2G06
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CEW
2001-12-13
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
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CEW
2001-11-20
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
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CEW
2001-07-02
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
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CEW
2001-04-30
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
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CEW
2000-08-21
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
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CEW
2000-04-11
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
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CEW
1999-09-28
ELECSYS PARATHYROID HORMONE TEST SYSTEM
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CEW
1999-07-06
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
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CEW
1997-12-23
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
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CEW
1997-10-31
ACTIVE INTACT PTH
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CEW
1997-04-14
AQUALITE INTACT PTH
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CEW
1996-12-10
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
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CEW
1996-09-27
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
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CEW
1995-11-03
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
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CEW
1995-07-19
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
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CEW
1995-07-17
ACTIVE INTACT PTH ELISA
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CEW
1995-04-13
ELSA-PTH
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CEW
1994-09-20
GAMMA-BCT INTACT PTH
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CEW
1994-09-07
OCTEIA INTACT PTH
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CEW
1993-12-10
IMMUNLITE INTACT PTH
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CEW
1993-06-15
COAT-A-COUNT INTACT PTH IRMA
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CEW
1992-09-02
COTUBE PTH IRMA
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CEW
1992-05-14
N-TACT(R) PTH SP KIT
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CEW
1991-10-25
VENTREX COATED TUBE INTACT PTH
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CEW
1990-09-25
LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY
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CEW
1990-07-16
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
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CEW
1989-11-21
DSL I-PTH (DSL #8000)
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CEW
1988-10-13
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
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CEW
1987-11-23
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
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CEW
1987-09-25
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
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CEW
1986-07-22
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
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CEW
1985-10-04
C-TERMINAL PTH RIA KIT
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CEW
1985-04-29
PTH-RIA
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CEW
1985-04-03
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
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CEW
1984-10-30
PARATHYROID HORMONE C-TERMINAL RIA KIT
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CEW
1984-10-30
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
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CEW
1984-10-11
C-TERMINAL/MID-MOLECULE PARATHYROID -
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CEW
1984-04-04
PARATHYROID HORMONE ANALYSIS PRODUCT
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CEW
1983-12-29
C. PTH RADIOIMMUNOASSAY KIT-CPTHK
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CEW
1983-06-22
PTH MR
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CEW
1983-06-16
DAC-CEL PTH KIT RD51
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CEW
1983-05-09
HUMAN INTRACT PARATHYROID HORMONE BY
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CEW
1983-04-06
MMH PTH RIA KIT
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CEW
1982-12-30
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
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CEW
1982-06-02
RADIOIMMUNOASSAY PARATHYROID HORMONE MID
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CEW
1982-03-11
MIN-MOLECULE PTH BY RADIOIMMUNOASSAY
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CEW
1981-12-03
C-TERMINAL PTH RIA TEST KIT, DSL-1000
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CEW
1981-06-25
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
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CEW
1981-06-24
N-TERMINAL HPTH BY RIA
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CEW
1979-09-27
PTH RIA 200
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CEW
1979-03-21
RIA SYSTEM, PARATHYROID HORMONE
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CEW
1979-01-10
HORMONE KIT, PARATHYROID
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CEW
1977-12-22
COMPLEMENT C3 NEPHELOMETRIC ASSAY
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CEW
1977-10-14
PTH RIA
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