JFJ

Product Code: JFJ

Products Classified as JFJ

382

Catalytic Methods, Amylase

Amylase Test System.

Total Product Life Cycle (TPLC) Devices

382

Catalytic Methods, Amylase

Amylase Test System.

Pre-market Notifications for JFJ

K210633	Amylase2	Abbott Ireland Diagnostics Division
K191454	Atellica CH Amylase_2 (AMY_2)	Siemens Healthcare Diagnostics Inc.
K182474	Alpha-AMYLASE DIRECT, Alpha-AMYLASE EPS, Alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL	BioSystems S.A.
K130685	HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY	HITACHI CHEMICAL DIAGNOSTICS, INC.
K122858	ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II	ELITECHGROUP
K091846	SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607	BECKMAN COULTER, INC.
K080823	EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT	MEDICA CORP.
K070064	AMYLASE EPS REAGENT	Thermo Fisher Scientific
K062180	ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP	HORIBA ABX
K051447	SENTINEL PANCREATIC AMYLASE	SENTINEL CH. SRL
K040920	AMYLASE LIQUID REAGENT, MODEL A532-200	TECO DIAGNOSTICS
K023549	WIENER LAB AMILASA 405 AA LIQUIDA	WIENER LABORATORIES S.A.I.C.
K020282	JAS AMYLASE LIQUID REAGENT	JAS Diagnostics, Inc.
K013978	SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT	BECKMAN COULTER, INC.
K013101	WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA	WIENER LABORATORIES S.A.I.C.

Global Unique Device Identification Database

• 00380740135461: CATALYTIC METHODS, AMYLASE
• 00380740012854: CATALYTIC METHODS, AMYLASE
• 00630414595641: CATALYTIC METHODS, AMYLASE
• 00630414510156: CATALYTIC METHODS, AMYLASE
• 00628063401062: CATALYTIC METHODS, AMYLASE
• 00628063400133: CATALYTIC METHODS, AMYLASE
• 00628063400126: CATALYTIC METHODS, AMYLASE
• 00657498001707: Catalytic Methods, Amylase
• 00657498000489: Catalytic Methods, Amylase
• 00817302022964: CATALYTIC METHODS, AMYLASE
• 00817302020304: CATALYTIC METHODS, AMYLASE
• 00817302020298: CATALYTIC METHODS, AMYLASE
• 00817302020281: CATALYTIC METHODS, AMYLASE
• 00817302020274: CATALYTIC METHODS, AMYLASE
• 00817274022849: Catalytic Methods, Amylase

Maude Adverse Events

DIMENSION?	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2018-04-12
DIMENSION?	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2018-04-12
COBAS INTEGRA AMMONIA 150	ROCHE DIAGNOSTICS	2012-07-27
DIMENSION VISTA? CHEMISTRY SYSTEM	SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW	2011-12-27
AMMONIA	ROCHE DIAGNOSTICS	2011-07-01
SYNCHRON? AMYLASE (AMY) REAGENT	BECKMAN COULTER, INC.	2010-09-21