GGN
A-FACT, ABNORMAL FACTOR ASSAY CONTROL
- Advisory panel
- Hematology
- Total cleared
- 99
Recent clearances under product code GGN
- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K161316 — George King Coumadin Plasma
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
- K150144 — VisuCon-F Low Fibrinogen Control Plasma
- K142132 — POOL NORM
- K133582 — HEMOSIL D-DIMER HS 500 CONTROL
- K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
- K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
- K120014 — STA- COAG CONTROL (N+ABN) PLUS
- K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
- K110432 — VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
- K100716 — AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
- K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07
- K103314 — CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
- K103313 — HEPARIN ASSAY CONTROLS
- K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
- K090563 — HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K082859 — HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
- K071319 — I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
- K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
- K063823 — COAGUCHEK XS PT CONTROLS
- K052697 — HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
- K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
- K050799 — TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
- K042760 — PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
- K042333 — CONTROL PLASMA N, PROC CONTROL PLASMA
- K042209 — CONTROL PLASMA N AND CONTROL PLASMA P
- K042175 — HEPARINASE HR ACT CONTROL, MODEL 550-12
- K042206 — PURPLE/BLACK HEPARIN ASSAY CONTROL
- K040275 — LYPHOCHEK HEMOSTASIS CONTROL
- K032611 — LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
- K032017 — LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
- K030965 — CONTROL PLASMA LMW HEPARIN
- K030182 — LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
- K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
- K012722 — LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
- K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
- K010324 — STA-QUALITY HBPM/LMWH KIT
- K010350 — STA -CALIBRATOR HBPM/LMWH KIT
- K000679 — THROMBOSTRATE CONTROL PLASMAS
- K994159 — HMP CONTROLS (TAS) RAPIDPOINT
- K991439 — POLLER CALIBRANTS
- K992829 — CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
- K992278 — HEPARIN CONTROL PLASMA LEVEL 1
- K992279 — HEPARIN CONTROL PLASMA LEVEL 2
- K990858 — LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
- K981752 — I-STAT COAGULATION CONTROL SET
- K981248 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
- K981254 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
- K981255 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
- K981178 — THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
- K980982 — AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
- K971219 — CRYO CHECK INR VALIDATION SET
- K971222 — CRYO CHECK APC RESISTANT PLASMA
- K964716 — STA LIATEST CONTROL [N]+[P] KIT
- K971428 — COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
- K971748 — TAS PT-NCTEST CONTROLS
- K964963 — LYPHOCHEK COAGULATION CONTROL
- K962674 — STA - VWF CONTROL [N]+[P] KIT
- K961189 — TAS A PTT TEST CONTROLS
- K955278 — BEHRING COAGULATION TIMER
- K960234 — TAS HMT CONTROLS
- K952321 — PORCINE FACTOR VIII;C REAGENT
- K951823 — CRYO CHECK LOW FIBRINOGEN CONTROL
- K952622 — CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
- K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL
- K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL
- K940209 — ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
- K943518 — STA SYSTEM CONTROL [N] + [P] KIT
- K944691 — ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
- K941860 — SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
- K933277 — COAGULATION A.R.P.
- K922887 — CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
- K924404 — CLIBRATION PLASMAS
- K922174 — COAG-CONTROL [N] KIT
- K921344 — THROMBO-CALIBRATOR KIT
- K914949 — COAGULATION ARPR,CAT.NO.5185
- K911777 — ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
- K905673 — AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
- K902361 — COAGULATION CONTROL, LEVEL I
- K902362 — COAGULATION CONTROL, LEVEL II
- K902363 — COAGULATION CONTROL, LEVEL III
- K902210 — ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
- K900019 — ROCKET REFERENCE PLASMA, CAT NO. 5188
- K884901 — DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
- K884854 — COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
- K882480 — HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
- K882481 — HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
- K881348 — VERIFY(R) REFERENCE PLASMA
- K880302 — CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
- K840288 — DIACELIN
- K834086 — CONTACT-K APTT REAGENT
- K771346 — CI-TROL COAGULATION CONTROLS II & III
Data sourced from openFDA. This site is unofficial and independent of the FDA.