CEP

Product Code: CEP

Products Classified as CEP

271

Radioimmunoassay, Luteinizing Hormone

Luteinizing Hormone Test System.

Total Product Life Cycle (TPLC) Devices

271

Radioimmunoassay, Luteinizing Hormone

Luteinizing Hormone Test System.

Pre-market Notifications for CEP

K022829	INSTANT-VIEW LH OVULATION PREDICTING TEST	ALFA SCIENTIFIC DESIGNS, INC.
K021409	AT HOME OVULATION TEST, MODEL 9032	PHAMATECH INC.
K013874	CLEARPLANE EASY OVULATION TEST	UNIPATH LTD.
K013582	MAYBE?MOM MINI OVULATION MICROSCOPE	MAYBE?MOM
K013323	TCI-31 LIFELONG OVULATION TESTER	TCI NEW YORK
K012252	QUIK-CHECK OVULATION PREDICTOR	ACON LABORATORIES, INC.
K010244	SURE CHECK OVULATION PREDICTOR	Chembio Diagnostic Systems, Inc.
K002867	INVERNESS MEDICAL OVULATION PREDICTOR TEST	SELFCARE, INC.
K991466	EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)	SELFCARE, INC.
K991386	EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)	SELFCARE, INC.
K990249	OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031	PHAMATECH
K983113	BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT	SYNTRON BIORESEARCH, INC.
K981271	CLEARPLAN EASY OVULATION TEST	UNIPATH LTD.
K974508	DBEST ONE-STEP OVULATION TEST	AMERITEK, INC.
K973310	TBD* ONE-STEP OVULATION PREDICTOR TEST	ARMKEL, LLC.

Global Unique Device Identification Database

• 00380740121549: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
• 00380740121532: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
• 00380740003937: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
• 00380740003920: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
• 10633472601207: Radioimmunoassay, Luteinizing Hormone
• 00630414961699: RADIOIMMUNOASSAY, LUTEINIZING HORMONE
• 00695684755409: Radioimmunoassay, Luteinizing Hormone
• 00695684755010: Radioimmunoassay, Luteinizing Hormone
• 00695684750305: Radioimmunoassay, Luteinizing Hormone
• 00760236169192: Radioimmunoassay, Luteinizing Hormone
• 00811727013262: Radioimmunoassay, Luteinizing Hormone
• 00857275007445: Radioimmunoassay, Luteinizing Hormone
• 10855944007366: Radioimmunoassay, Luteinizing Hormone
• 10855944007359: Radioimmunoassay, Luteinizing Hormone
• 10855944007199: Radioimmunoassay, Luteinizing Hormone

Maude Adverse Events

VIDAS LH	BIOM?RIEUX SA	2015-06-05
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER	2014-10-06
ACCESS HLH	BECKMAN COULTER, INC.	2011-10-28
ACCESS? HLH REAGENT	BECKMAN COULTER, INC.	2011-06-07
ACCESS? HLH CALIBRATORS	BECKMAN COULTER, INC.	2011-02-07
ARCHITECT INSULIN	ABBOTT LABORATORIES	2008-05-15
ARCHITECT INSULIN	ABBOTT LABORATORIES	2008-04-29
ARCHITECT LH	ABBOTT LABORATORIES	2007-08-10
ARCHITECT LH	ABBOTT LABORATORIES	2007-07-26
ARCHITECT LH	ABBOTT LABORATORIES	2007-07-26
ARCHITECT LH	ABBOTT LABORATORIES	2007-01-09
ARCHITECT LH	ABBOTT LABORATORIES	2007-01-04
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-28
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-27
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-27
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-27
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-27
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-26
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-13
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-12
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-12
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-12
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECH LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07
ARCHITECT LH	ABBOTT LABORATORIES	2006-12-07