GHH

Product Code: GHH


Products Classified as GHH

2270Fibrin Split ProductsFibrinogen/fibrin Degradation Products Assay.

Total Product Life Cycle (TPLC) Devices

2270Fibrin Split ProductsFibrinogen/fibrin Degradation Products Assay.

FDA Consensus Standards

Fibrin Split Products [21764]21 CFR §864.7320 🔎
Fibrin Split Products [31795]21 CFR §864.7320 🔎

Pre-market Notifications for GHH

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDIAZYME LABORATORIES
K072288PATHFAST D-DIMERMITSUBISHI KAGAKU IATRON
K070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
K062203TINA-QUANT D-DIMER TEST SYSTEMROCHE DIAGNOSTICS CORP.
K042890TRIAGE D-DIMER TEST, MODEL 98100BIOSITE INCORPORATED
K030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMROCHE DIAGNOSTICS CORP.
K021877MDA D-DIMERBIOMERIEUX, INC.
K011143TINA-QUANT D-DIMER TEST SYSTEMROCHE DIAGNOSTICS CORP.
K993276SIMPLIFY D-DIMER, MODEL DCGK1AGEN BIOMEDICAL LTD.
K972316OPUS D-DIMERBEHRING DIAGNOSTICS, INC.
K945642AGEN DIMERTEST GOLD EIAAGEN BIOMEDICAL LTD.
K921989FDP - SLIDEX DIRECTBIOMERIEUX VITEK, INC.
K920668MINUTEX D-DIMER LATEX TESTBIOPOOL AB
K905643BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYAGEN BIOMEDICAL LTD.
K893961ABBOTT IMX(TM) D-DIMERABBOTT LABORATORIES

Global Unique Device Identification Database

00816426020665Fibrin Split Products
00816426020368Fibrin Split Products
00845275000900Fibrin Split Products
00845275000894Fibrin Split Products
00845275000887Fibrin Split Products
00845275000870Fibrin Split Products
00845275000863Fibrin Split Products
04987595301537Fibrin Split Products
15391521420760Fibrin Split Products
15099590080884Fibrin Split Products
15099590070588Fibrin Split Products
15099590000332Fibrin Split Products
07613336133651FIBRIN SPLIT PRODUCTS
03607450004540FIBRIN SPLIT PRODUCTS

Maude Adverse Events

TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2020-03-27
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2020-03-19
D-DIMERROCHE DIAGNOSTICS2019-11-13
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-11-08
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-11-08
D-DIMERROCHE DIAGNOSTICS2019-10-03
TRIAGE D-DIMER TESTQUIDEL CARDIOVASCULAR INC.2019-10-02
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-09-17
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-08-14
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-08-14
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2019-08-08
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-07-18
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-07-18
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2019-07-03
D-DI TINA-QUANT D-DIMER GEN. 2ROCHE DIAGNOSTICS2019-06-24
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-06-18
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2019-06-11
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2019-05-07
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2019-02-12
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2019-02-07
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2018-12-13
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-11-28
D-DIMERROCHE DIAGNOSTICS2018-11-19
D-DIMERROCHE DIAGNOSTICS2018-10-22
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-10-05
D-DIMERROCHE DIAGNOSTICS2018-09-12
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2018-09-06
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2018-09-06
D-DIMERROCHE DIAGNOSTICS2018-08-27
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR, INC.2018-08-17
D-DIMERROCHE DIAGNOSTICS2018-07-19
D-DIMERROCHE DIAGNOSTICS2018-07-13
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-06-29
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR, INC.2018-05-14
D-DIMERROCHE DIAGNOSTICS2018-05-11
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR, INC.2018-05-11
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-04-20
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-04-13
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2018-01-12
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2017-12-15
D-DIMERROCHE DIAGNOSTICS2017-12-07
TRIAGE D-DIMER PANELQUIDEL CARDIOVASCULAR INC.2017-12-05
D-DIMERROCHE DIAGNOSTICS2017-11-16
D-DIMERROCHE DIAGNOSTICS2017-10-17
TRIAGE D-DIMER PANELALERE SAN DIEGO, INC.2017-10-12
TRIAGE D-DIMER PANELALERE SAN DIEGO, INC.2017-10-12
TRIAGE D-DIMER PANELALERE SAN DIEGO, INC.2017-10-11
ROCHE CARDIAC D-DIMERROCHE DIAGNOSTICS2017-09-26
D-DIMERROCHE DIAGNOSTICS2017-09-25
TRIAGE D-DIMER PANELALERE SAN DIEGO, INC.2017-09-01

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