System, Test, Low Density, Lipoprotein
FDA product code MRR · 31 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.1475
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1990-03-19 – 2024-07-26
MRR
2024-07-26
MRR
2023-07-19
AXINON® LDL-p Test System
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MRR
2017-03-20
Direct LDL Cholesterol (LDL)
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MRR
2009-08-03
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
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MRR
2009-07-17
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
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MRR
2008-07-23
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
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MRR
2005-08-08
DIRECT LDL CHOLESTEROL, MODEL L530-60H
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MRR
2005-01-26
LDL-EX SEIKEN ASSAY KIT
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MRR
2004-11-23
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
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MRR
2004-08-25
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
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MRR
2004-07-06
PTS PANELS LDL CHOLESTEROL TEST STRIPS
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MRR
2002-09-17
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
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MRR
2002-05-09
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
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MRR
2002-04-12
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
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MRR
2002-01-28
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
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MRR
2001-08-07
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
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MRR
2000-07-03
EZ LDL CHOLESTEROL TEST SYSTEM
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MRR
1999-10-18
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
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MRR
1999-07-13
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
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MRR
1999-01-28
RDI DIRECT LDL CHOLESTEROL TEST
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MRR
1998-10-01
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
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MRR
1998-09-22
WAKO DIRECT LDL-C
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MRR
1998-09-11
RANDOX DIRECT LDL CHOLESTEROL
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MRR
1998-08-03
DIRECT LDL
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MRR
1998-07-22
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
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MRR
1996-11-20
RDI LIPIDIRECT MAGNETIC LDL REAGENT
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MRR
1996-11-20
RDI LDL PRECIPITATION REAGENT
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MRR
1996-05-24
EKTACHEM DT LDL CHOLESTEROL KIT
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MRR
1995-03-15
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
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MRR
1993-01-06
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
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MRR
1990-03-19
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
View details →No matching devices.
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