GJT

Product Code: GJT


Products Classified as GJT

2300Plasma, Coagulation Factor DeficientFactor Deficiency Test.

Total Product Life Cycle (TPLC) Devices

2300Plasma, Coagulation Factor DeficientFactor Deficiency Test.

FDA Consensus Standards

Plasma, Coagulation Factor Deficient [21764]21 CFR §864.7290 🔎
Plasma, Coagulation Factor Deficient [26729]21 CFR §864.7290 🔎

Pre-market Notifications for GJT

K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory Co.
K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K102908NOFACT IXR2 DIAGNOSTICS, INC.
K102851NOFACT VIIIR2 DIAGNOSTICS, INC.
K050661HEMOSIL FACTOR II DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K043459HEMOSIL FACTOR XII DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K040362DIAPHARMA FACTOR X KITDIAPHARMA GROUP, INC.
K034007HEMOSIL FACTOR VIII DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K031829HEMOSIL FACTOR IX DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K031122HEMOSIL FACTOR X DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K030287HEMOSIL FACTOR XI DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K024082HEMOSIL FACTOR VII DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K023839HEMOSIL FACTOR V DEFICIENT PLASMAINSTRUMENTATION LABORATORY CO.
K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15PRECISION BIOLOGIC
K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)PRECISION BIOLOGIC

Global Unique Device Identification Database

00815696021082Plasma, Coagulation Factor Deficient
00815696021075Plasma, Coagulation Factor Deficient
00815696021037Plasma, Coagulation Factor Deficient
00815696021020Plasma, Coagulation Factor Deficient
00815696021013Plasma, Coagulation Factor Deficient
00815696021006Plasma, Coagulation Factor Deficient
00815696020993Plasma, Coagulation Factor Deficient
00815696020948Plasma, Coagulation Factor Deficient
00815696020931Plasma, Coagulation Factor Deficient
00815696020924Plasma, Coagulation Factor Deficient
00815696020917Plasma, Coagulation Factor Deficient
00815696020825Plasma, Coagulation Factor Deficient
00815696020818Plasma, Coagulation Factor Deficient
00815696020801Plasma, Coagulation Factor Deficient
00815696020795Plasma, Coagulation Factor Deficient

Maude Adverse Events

CLOTTING FACTOR V DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2020-03-13
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-09-19
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-09-19
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-09-19
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-09-19
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH2018-09-19
COAGULATION FACTOR VIII DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-01-04
COAGULATION FACTOR VIII DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-03-03
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2013-12-06
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2013-12-06
COAGULATION FACTOR IX DEFICIENT PLASMASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2013-12-06
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