BEUDAMED
    Product Code: CIT FDA class 2 21 CFR 862.1100

    Nadh Oxidation/Nad Reduction, Ast/Sgot

    Clinical Chemistry

    The NADH Oxidation/NAD Reduction, AST/SGOT test system (product code CIT) is an in-vitro diagnostic device used in clinical chemistry to measure aspartate aminotransferase (AST/SGOT) activity in serum using a coupled enzymatic reaction monitored by NADH oxidation or NAD reduction spectrophotometrically. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1100 in the Clinical Chemistry medical specialty.

    View on FDA
    510(k)s
    139
    FEI Numbers
    53
    Registration Numbers
    53
    Unique Applicants
    81
    Years Active
    34

    Basic Information

    Product Code
    CIT
    Device Class
    FDA class 2
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 139 510(k) clearances via K numbers.

    K Number Device Name
    K093883 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
    K080485 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
    K071525 ACTIVATED ASPARTATE AMINOTRANSFERASE
    K071580 AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
    K071211 COBAS C 111 ANALYZER
    K060318 HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
    K023551 WIENER LAB GOT (AST) UV AA LIQUIDA
    K013698 AST (SGOT)
    K013145 WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
    K010488 ATAC PAK AST REAGENT KIT
    K001679 VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
    K993468 WAKO L-TYPE GOT TEST
    K992136 BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
    K992801 SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
    K991663 AST/SGOT
    K990009 CARESIDE AST
    K983131 AST
    K981843 AST
    K981650 AST/SGOT LIQUID REAGENT - KINETIC METHOD
    K981225 ASPARTATE AMINOTRANSFERASE (AST)
    K981221 ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
    K980902 N-ASSAY L AST/GOT
    K980666 INFINITY AST REAGENT (PROCEDURE NO. 51)
    K980030 AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K974001 ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
    K971344 AST OR SGOT
    K965126 AST/SGOT
    K961114 AST INCORPORATING DST
    K954992 ROCHE COBAS INTEGRA REAGENT CASSETTES
    K954839 ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
    K952743 ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
    K951751 HICHEM AST REAGENT KIT
    K944102 AST QVET
    K941132 LIQUID AST (SGOT)REAGENT SET
    K934413 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
    K935181 ASPARTATE AMINOTRANSFERASE (AST) TEST
    K932049 STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
    K925155 OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
    K924244 ROCHE REAGENT FOR AST
    K923505 AST (GOT) - ASPARTATE AMINOTRANSFERASE
    K923641 IL TEST AST, PN 35312
    K922857 SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
    K922885 OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
    K922108 KING DIAGNOSTICS AST (GOT) REAGENT
    K920336 MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
    K915555 SYNERMED AST/GOT REAGENT KIT
    K914463 ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
    K914025 TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
    K914068 ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
    K905771 COULTER DART AST (GOT) REAGENT
    K903829 AST REAGENT
    K903197 ASPARTATE AMINOTRANSFERASE TEST
    K901104 PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
    K897165 COULTER AST (GOT) REAGENT
    K896233 COBAS READY LIVER PROFILE REAGENT STRIP
    K896229 COBAS READY PROFILE 1 REAGENT STRIP
    K896228 COBAS READY CARDIO PROFILE REAGENT STRIP
    K896000 ASPARTATE AMINOTRANFERASE (AST)
    K894180 ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
    K893692 EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
    K892844 AST REAGENT (PROCEDURE NUMBER 158)
    K891468 AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
    K884724 ASPARTATE AMINOTRANSFERASE (AST)
    K885156 CLINISTAT SGOT (AST) REAGENT TEST
    K884377 ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
    K880692 ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
    K880276 AST (SGOT) REAGENT SET
    K875071 ASPARTATE AMINOTRANSFERASE AST/SGOT
    K874600 EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
    K872829 BIOTROL AST/TGO MONOREACTIF
    K871780 ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
    K870077 ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
    K870246 REFLOTRON(R) AST (GOT)
    K864813 WAKO (TM) AUTOKIT GOT TEST
    K864357 AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
    K863054 AST S.C.E. (GOT)
    K864302 WAKO(TM) GOT II - HA
    K863963 EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
    K863257 AST/GOT PROCEDURE
    K863094 SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
    K862832 MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
    K861656 AST/GOT PROCEDURE
    K860465 VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
    K861283 AST REAGENT CARTRIDGE
    K860725 AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
    K860667 ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
    K854982 VISION SGOT (AST)
    K854503 AST(OPTIMIZED) REAGENT
    K852783 SGOT/ALT REAGENT
    K851994 AST ASPARTATE AMINOTRANSFERASE REAGENT
    K851865 AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
    K851267 GEMENI AST-LTS REAGENTS
    K843109 ROCHE REAGENT FOR AST
    K843333 SYSTEMATE GOT 67208
    K842521 AST/GOT REAGENT SET UV RATE
    K842411 SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
    K842245 ASPARTATE AMINOTRANSFERASE ASSAY KIT
    K841066 SGOT-UV REAGENT SET
    K840706 ASPARTATE AMINOTRANSFERASE REAGENT
    K830958 FLOW-PAC SGOT REAGENT
    K822493 OPTIMIZED UV-GOT REAGENT SET
    K821208 SGOT-UV REAGENT SET
    K821876 ULTRAZYME PLUS GOT
    K821433 BECKMAN LIQUID-STAT AST-UV LIQUID
    K821467 ULTRAZYME PLUS GOT, #64953,65033&65034
    K820270 RAICHEM GOT (AST) REAGENT
    K813405 AST(SGOT) IN VITRO DIAG. REAGENT SET
    K812592 ULTRA ZYME PLUS GOT #64953, 65033 & 34
    K802447 GOT ISOENZYME ASSAY EIKEN KIT
    K810727 AST-UV (PLP-ACTIVATED) DETERMINATION
    K810390 AST (UV) TEST
    K803216 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
    K801856 DATA-ZYME AST(GOT) PROCEDURE
    K801118 COBAS REAGENT FOR AST (SGOT)
    K800688 REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC
    K800641 CENTRIFI CHEM AST/SGOT
    K800116 DURAZYME GOT/AST
    K800065 ASI REAGENT
    K792208 DURAZYME GOT/AST
    K791679 NADH OXIDATION, AST/SGOT
    K791080 PLUS CHEM S.C.E. REAGENT
    K791082 SPIN CHEM REAGENT, DETERMINATION OF AST
    K790483 COULTER ACCU-ZYME II GOT REAGENT
    K790017 SERUM, GLUTAMIC-OXALOACETIC
    K781784 AST
    K781725 REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
    K781020 (AST) OR (ALT) UV DETERM. PHY. PHOS.
    K780634 SINGLE VIAL 10 SGOT-TRIS
    K780463 AST(GOT) UNI-UV, SGOT
    K780505 SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
    K780443 SGOT/AST REAGENT SYSTEM
    K780103 ULTRAZYME PLUS GOT
    K780039 ASPARTATE TRANSAMINASE
    K780013 SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
    K772029 GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
    K771153 DYNA ZYME II GOT 340
    K770318 REAGENT GOT, ENZYME
    K760193 NDC#12739-0011-1 C-ZYME GOT
    K760010 COLORIMETRIC DETERMINATION (SGOT/SGPT)

    FEI Numbers

    This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.