NAL

Product Code: NAL

Products Classified as NAL

626

Test, Immunoassay, Biosensor, Hcg

Human Chorionic Gonadotropin (HCG) Test System.

Total Product Life Cycle (TPLC) Devices

626

Test, Immunoassay, Biosensor, Hcg

Human Chorionic Gonadotropin (HCG) Test System.

Pre-market Notifications for NAL

K990258

QUANTECH TOTAL B-HCG ASSAY

QUANTECH LTD.

Maude Adverse Events

I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-08-26
ARCHITECT I1000SR ANALYZER	ABBOTT MANUFACTURING INC	2016-05-27
COBAS 8000 E602 MODULE	ROCHE DIAGNOSTICS	2016-05-27
ADVIA CENTAUR XP	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2016-05-23
DIMENSION RXL MAX WITH HM	SIEMENS HEALTHCARE DIAGNOSTICS INC	2016-05-23
COBAS 6000 E601 MODULE	ROCHE DIAGNOSTICS	2016-05-20
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-20
ADVIA CENTAUR CP	SIEMENS HEALTHCARE DIAGNOSTICS INC.	2016-05-20
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-13
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-13
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-13
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-13
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-05-13
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-04-26
ACCESS 2 IMMUNOASSAY ANALYZER	BECKMAN COULTER	2016-03-30
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-03-23
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-02-26
COBAS 8000 E602 MODULE	ROCHE DIAGNOSTICS	2016-02-10
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-02-05
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2016-02-01
ARCHITECT I2000SR ANALYZER	ABBOTT MANUFACTURING INC	2016-01-08
ACCESS 2 IMMUNOASSAY ANALYZER	BECKMAN COULTER	2015-12-02
COBAS 6000 E601 MODULE	ROCHE DIAGNOSTICS	2015-12-02
I-STAT B-HCG CARTRIDGE	ABBOTT POINT OF CARE	2015-11-20
ARCHITECT I2000SR ANALYZER	ABBOTT MANUFACTURING INC	2015-11-10
ARCHITECT I2000SR ANALYZER	ABBOTT MANUFACTURING INC	2015-09-01
COBAS 6000 E601 MODULE	ROCHE DIAGNOSTICS	2010-04-13
COBAS 6000 E601 MODULE	ROCHE DIAGNOSTICS	2010-04-12
COBAS 6000 E601 MODULE	ROCHE DIAGNOSTICS	2010-04-12