Catalytic Methods, Amylase
FDA product code JFJ · 99 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1070
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-07-05 – 2022-05-26
JFJ
2022-05-26
JFJ
2019-07-30
Atellica CH Amylase_2 (AMY_2)
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JFJ
2019-05-02
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
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JFJ
2013-08-09
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
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JFJ
2012-10-03
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
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JFJ
2009-10-16
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
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JFJ
2008-11-17
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
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JFJ
2007-05-22
AMYLASE EPS REAGENT
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JFJ
2006-10-02
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
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JFJ
2006-01-26
SENTINEL PANCREATIC AMYLASE
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JFJ
2004-05-10
AMYLASE LIQUID REAGENT, MODEL A532-200
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JFJ
2004-03-11
VITALAB AMYLASE REAGENT
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JFJ
2002-12-09
WIENER LAB AMILASA 405 AA LIQUIDA
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JFJ
2002-02-28
JAS AMYLASE LIQUID REAGENT
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JFJ
2002-01-15
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
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JFJ
2001-11-16
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
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JFJ
2001-08-10
GENZYME DIRECT-AMYLASE TEST REAGENT
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JFJ
2001-06-25
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
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JFJ
2000-06-26
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
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JFJ
1999-02-08
CARESIDE AMYLASE
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JFJ
1999-01-13
WAKO L-TYPE AMYLASE
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JFJ
1998-08-28
AMY
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JFJ
1998-06-08
AMY
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JFJ
1997-12-17
IL TEST AMYLASE
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JFJ
1997-12-08
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
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JFJ
1997-08-12
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
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JFJ
1997-07-24
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
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JFJ
1997-07-17
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
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JFJ
1995-05-15
ACE AMYLASE REAGENT
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JFJ
1995-02-08
CATALOGUE NUMBER 321-07/15/50
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JFJ
1994-12-09
OLYMPUS AMYLASE REAGENT
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JFJ
1994-12-09
AMYLASE QVET
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JFJ
1994-09-09
DUPONT DIMENSION AMYLASE METHOD
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JFJ
1994-07-06
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
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JFJ
1994-05-03
SYNERMED AMYLASE REAGENT KIT
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JFJ
1994-04-12
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
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JFJ
1994-04-06
AMYLASE
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JFJ
1994-01-31
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
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JFJ
1993-11-05
AMYLASE REAGENT SET (KINETIC)
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JFJ
1993-10-28
GENZYME A-AMYLASE TEST REAGENT
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JFJ
1993-08-19
SILYL AMYL
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JFJ
1993-08-19
ETHYLIDENE AMYL
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JFJ
1993-07-19
LIQUID AMYLASE REAGENT SET
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JFJ
1992-10-02
OLYMPUS AMYLASE REAGENT
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JFJ
1992-09-28
MILES URINE AMYLASE METHOD
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JFJ
1992-09-09
AMYLASE TEST
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JFJ
1992-03-27
AMYLASE REAGENT
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JFJ
1992-03-02
ABBOTT QUICKSTART AMYLASE, #5AXX
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JFJ
1992-02-18
IL TEST(TM) AMLYLASE
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JFJ
1992-01-30
AMYLASE (COLORIMETRIC) REAGENT SET
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JFJ
1991-09-11
AMYLASE REAGENT (PROCEDURE 577)
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JFJ
1991-07-01
AMYLASE REAGENT
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JFJ
1991-04-30
AMYLASE
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JFJ
1991-01-31
KINETIC AMYLASE DETERMINATION
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JFJ
1990-09-07
ROCHE COBAS READY AMYLASE REAGENT
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JFJ
1990-08-17
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
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JFJ
1990-07-31
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
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JFJ
1990-05-15
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
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JFJ
1990-04-03
COULTER AMYLASE REAGENT
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JFJ
1990-02-08
AMYLASE REAGENT
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JFJ
1989-08-17
AMYLASE TEST (AML) ITEM NUMBER: 65404
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JFJ
1989-08-15
ABBOTT SPECTRUM AMYLASE REAGENT
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JFJ
1989-07-20
PANCREATIC A-AMYLASE PNP
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JFJ
1989-02-17
AMYLASE SR LIQUID STABLE REAGENT SET
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JFJ
1988-04-19
AMYLASE 405 CATALOG NUMBER 301-34
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JFJ
1988-01-05
REFLOTRON (R) AMYLASE
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JFJ
1987-11-23
A-GENT LIQUID AMYLASE
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JFJ
1987-10-06
BNP-AMYLASE TEST
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JFJ
1987-08-05
AMYLASE TEST KIT
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JFJ
1987-06-01
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
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JFJ
1987-04-13
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
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JFJ
1987-02-20
AMYLASE COLORIMETRIC PROCEDURE
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JFJ
1987-01-21
PSI AMYLASE REAGENT
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JFJ
1986-12-31
QKO (TM) AMYLASE B-HA
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JFJ
1986-12-16
VISION(TM) AMYLASE
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JFJ
1986-10-03
TDX(R) AMYLASE II
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JFJ
1986-09-29
AMYLASE PROCEDURE
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JFJ
1986-09-29
AMYLASE SR LIQUID STABLE REAGENT SET
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JFJ
1986-05-29
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
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JFJ
1986-05-29
RAICHEM AMYLASE REAGENT
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JFJ
1986-04-07
ALPHA-AMYLASE TEST
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JFJ
1986-04-03
EASY-TEST AMLASE (AMYL), #67521/93
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JFJ
1986-03-14
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
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JFJ
1985-06-10
AMY REAGENT
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JFJ
1985-03-14
AMYLASE PRODUCTS
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JFJ
1983-11-25
AMYLASE
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JFJ
1983-07-07
AMYLAST-D TEST
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JFJ
1983-06-17
PARAMAX AMALINE REAGENT
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JFJ
1982-12-28
SINGLE VIAL AMYLASE PNP TEST
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JFJ
1982-07-13
ULTRAZYME PLUS AMYL
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JFJ
1982-05-28
ULTRAZYME PLUS AMYL #65031&64982
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JFJ
1980-11-12
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
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JFJ
1980-07-08
COBAS REAGENT FOR A-AMYLASE
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JFJ
1980-01-23
DELTA TEST AMYLASE UV
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JFJ
1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
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JFJ
1977-09-13
MULTISTAT III, AMYLASE TEST
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JFJ
1977-09-02
AMYLASE ULTRAZYME PLUS
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JFJ
1977-07-21
CLINICARD UV AMYLASE CHEMISTRY
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JFJ
1977-07-05
REAGENT KIT, ENZYMATIC AMYLASE
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