Nadh Oxidation/Nad Reduction, Alt/Sgpt

FDA product code CKA · 127 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1030
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-03 – 2013-06-07

CKA 2013-06-07

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST

Applicant Hitachi Chemical Diagnostics, Inc.

K number K120945

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CKA 2012-07-19

ACE ALT REAGENT

Applicant Alfa Wassermann

K number K113382

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CKA 2006-05-10

DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE

Applicant Dade Behring, Inc.

K number K061020

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CKA 2002-06-04

CARESIDE ALT

Applicant Careside, Inc.

K number K020487

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CKA 1998-02-02

ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

Applicant Trace America, Inc.

K number K980028

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CKA 1998-01-07

TRACE REAGENT LINE FOR THE COBAS MIRA

Applicant Trace America, Inc.

K number K973869

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CKA 1997-12-05

ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30

Applicant Diagnostic Chemicals , Ltd.

K number K974003

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CKA 1997-04-21

ALT OR SGPT

Applicant Carolina Liquid Chemistries Corp.

K number K971323

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CKA 1997-02-18

ALT/SGPT

Applicant Derma Media Lab., Inc.

K number K965134

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CKA 1996-04-25

ALT INCORPORATING DST

Applicant Trace Scientific , Ltd.

K number K961123

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CKA 1995-09-21

CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE

Applicant Beckman Instruments, Inc.

K number K952427

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CKA 1995-08-07

ALANINE AMINOTRANSFERASE REAGENT SYSTEM

Applicant Medical Diagnostic Technologies, Inc.

K number K952744

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CKA 1995-06-19

PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT

Applicant Dade Intl., Inc.

K number K951332

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CKA 1995-05-15

HICHEM ALT REAGENT KIT

Applicant Hi Chem, Inc.

K number K951818

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CKA 1994-11-22

ALT QVET

Applicant Prisma Systems

K number K944080

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CKA 1994-07-20

STANBIO ALT/GPT (LUQUI-UV) TEST SET

Applicant Stanbio Laboratory

K number K941314

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CKA 1994-05-24

SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY

Applicant Solarcare, Inc.

K number K941497

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CKA 1994-05-03

LIQUID ALT(SGPT) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K941287

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CKA 1994-01-13

ALANINE AMINOTRANSFERASE (ALT) TEST

Applicant Em Diagnostic Systems, Inc.

K number K935180

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CKA 1993-04-08

HEMOCARD HEMOGLOBIN E

Applicant Isolab, Inc.

K number K930070

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CKA 1993-02-05

OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT

Applicant Olympus Corp.

K number K925339

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CKA 1992-11-16

ALT (GPT) - ALANINE AMINOTRANSFERASE

Applicant Randox Laboratories, Ltd.

K number K923510

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CKA 1992-10-22

ROCHE REAGENT FOR ALT

Applicant Roche Diagnostic Systems, Inc.

K number K924245

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CKA 1992-09-28

EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000

Applicant Em Diagnostic Systems, Inc.

K number K923257

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CKA 1992-09-17

IL TEST ALT, PN 35311

Applicant Instrumentation Laboratory CO

K number K923623

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CKA 1992-07-28

OLYMPUS ALANINE AMINOTRANSFERASE REAGENT

Applicant Olympus Corp.

K number K922884

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CKA 1992-06-04

KING DIAGNOSTICS ALT (GPT) REAGENT

Applicant King Diagnostics, Inc.

K number K922109

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CKA 1992-05-07

SYNERMED ALT/GPT REAGENT KIT

Applicant Synermed, Inc.

K number K921016

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CKA 1992-03-24

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD

Applicant Heraeus Kulzer, Inc.

K number K920335

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CKA 1991-11-22

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43

Applicant Em Diagnostic Systems, Inc.

K number K914464

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CKA 1991-09-19

ABBOTT QUICKSTART ALANINE AMINOTRANSFER

Applicant Em Diagnostic Systems, Inc.

K number K913846

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CKA 1991-01-25

COULTER DART ALT (GPT) REAGENT

Applicant Coulter Electronics, Inc.

K number K905767

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CKA 1990-09-12

ALANINE AMINOTRANSFERASE TEST

Applicant Em Diagnostic Systems, Inc.

K number K903198

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CKA 1990-04-25

NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

Applicant American Research Products Co.

K number K901702

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CKA 1990-04-03

TECHNICON AXON SYSTEM REAGENT METHODS

Applicant Technicon Instruments Corp.

K number K900905

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CKA 1990-03-23

PARAMAX ALANINE AMINOTRANSFERASE REAGENT

Applicant Baxter Healthcare Corp

K number K901105

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CKA 1990-03-09

COULTER ALT (GPT) REAGENT

Applicant Coulter Electronics, Inc.

K number K897163

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CKA 1990-02-16

COBAS READY STAT PROFILE REAGENT STRIP

Applicant Roche Diagnostic Systems, Inc.

K number K896234

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CKA 1989-11-13

ALANINE AMINOTRANSFERASE (ALT)

Applicant American Monitor Corp.

K number K896001

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CKA 1989-07-27

TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES

Applicant Technicon Instruments Corp.

K number K892930

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CKA 1989-07-20

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403

Applicant Em Diagnostic Systems, Inc.

K number K893752

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CKA 1989-07-20

ALT REAGENT (PROCEDURE NUMBER 159)

Applicant Sigma Chemical Co.

K number K893560

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CKA 1989-04-10

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)

Applicant Abbott Laboratories

K number K890698

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CKA 1989-04-04

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

Applicant Trace Scientific , Ltd.

K number K891469

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CKA 1989-02-02

CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN

Applicant Heraeus Kulzer, Inc.

K number K885144

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CKA 1989-01-11

ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652

Applicant Em Diagnostic Systems, Inc.

K number K884376

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CKA 1989-01-03

ALANINE AMINOTRANSFERASE

Applicant Catachem, Inc.

K number K884936

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CKA 1988-09-19

SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE

Applicant Beckman Instruments, Inc.

K number K883181

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CKA 1988-09-09

ALTLTS ALANINE AMINO TRANSFERASE ALT

Applicant Electro-Nucleonics, Inc.

K number K883205

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CKA 1988-04-05

MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE

Applicant Miles Laboratories, Inc.

K number K875079

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CKA 1988-03-01

ALT (SGPT) REAGENT SET

Applicant Tech-Neal Scientific, Inc.

K number K880275

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CKA 1988-01-21

PYRIDOXAL-5-PHOSPHATE TABLETS

Applicant Boehringer Mannheim Corp.

K number K874835

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CKA 1988-01-21

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017

Applicant Em Diagnostic Systems, Inc.

K number K874586

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CKA 1987-08-19

MODIFIED ALT (GPT) REAGENT

Applicant Trace Scientific , Ltd.

K number K872483

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CKA 1987-08-13

BIOTROL ALT/TGP MONOREACTIF

Applicant Biotrol, USA, Inc.

K number K872830

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CKA 1987-05-26

ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)

Applicant Biochemical Trade, Inc.

K number K871782

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CKA 1987-03-19

ALANINE TRANSAMINASE (ALT) TEST KIT

Applicant Genetic Systems Corp.

K number K870879

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CKA 1987-03-06

ALANINE AMINOTRANSFERASE (ALT)/(GPT)

Applicant Catachem, Inc.

K number K870086

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CKA 1987-01-09

WAKO(TM) AUTOKIT GPT

Applicant Wako Chemicals USA, Inc.

K number K864850

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CKA 1986-12-31

ALANINE AMINO TRANSFERASE ALT/SGPT

Applicant Tech-Co, Inc.

K number K864906

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CKA 1986-12-16

WAKO GPT II - HA

Applicant Wako Chemicals USA, Inc.

K number K864335

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CKA 1986-12-10

ALT S.C.E. (GPT)

Applicant J. D. Assoc.

K number K863053

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CKA 1986-11-28

EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95

Applicant Em Diagnostic Systems, Inc.

K number K863962

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CKA 1986-09-16

ALT/GPT PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863253

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CKA 1986-08-19

MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K862833

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CKA 1986-07-29

TWIN GOT-AST IFCC/GPT-ALT IFCC

Applicant Boehringer Mannheim Corp.

K number K861792

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CKA 1986-06-25

ALT (SGPT) REAGENT SET (UV RATE)

Applicant Sterling Diagnostics, Inc.

K number K862209

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CKA 1986-06-25

ALT-30, 60 AND 100

Applicant Dimension Diagnostics

K number K861366

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CKA 1986-05-29

ALT/GPT PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861658

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CKA 1986-04-28

ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

Applicant Hi Chem, Inc.

K number K861231

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CKA 1986-04-21

VISION SGPT (ALT)

Applicant Abbott Laboratories

K number K861002

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CKA 1986-04-07

ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT

Applicant Trace Scientific , Ltd.

K number K860727

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CKA 1986-02-11

GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET

Applicant Technostics Intl.

K number K860110

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CKA 1985-12-25

IN VITRO TEST DETERMINATION OF SGPT(ALT)

Applicant Clinical Data, Inc.

K number K854186

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CKA 1985-11-25

ALT(OPTIMIZED) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K854502

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CKA 1985-08-29

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE

Applicant Hi Chem, Inc.

K number K852867

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CKA 1985-05-30

ALT (ALANINE AMINO-THRANSFERASE)REAGENT

Applicant Alpkem Corp.

K number K851995

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CKA 1985-05-24

AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE

Applicant Amresco, Inc.

K number K851923

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CKA 1985-01-08

ALT/GPT REAGENT SET

Applicant Sterling Biochemical, Inc.

K number K844251

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CKA 1984-10-05

ROCHE REAGENT FOR ALT

Applicant Roche Diagnostic Systems, Inc.

K number K843111

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CKA 1984-09-20

SYSTEMATE GPT 67209

Applicant Em Diagnostic Systems, Inc.

K number K843334

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CKA 1984-08-12

SIGMA 59-UV FOR ALANINE AMINOTRANSFER

Applicant Sigma Chemical Co.

K number K842564

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CKA 1984-07-18

ALANINE AMINOTRANSFERASE ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842241

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CKA 1984-05-01

SGPT REAGENT SET

Applicant Medical Specialties, Inc.

K number K841060

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CKA 1984-03-09

PARAMAX ALANINE AMINOTRANSFERASE

Applicant American Dade

K number K840705

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CKA 1983-09-12

ALT -LTS

Applicant Electro-Nucleonics Laboratories, Inc.

K number K832639

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CKA 1983-05-04

FLOW-PAC SGPT REAGENT

Applicant Amresco, Inc.

K number K830959

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CKA 1982-09-21

OPTIMIZED UV-GPT REAGENT SET

Applicant Biorent Diagnostic, Inc.

K number K822494

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CKA 1982-07-22

SGPT-UV REAGENT SET

Applicant Omega Medical Electronics

K number K821206

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CKA 1982-07-20

ALT ENZYME ASSAY KIT

Applicant Travenol Laboratories, S.A.

K number K821946

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CKA 1982-07-14

ULTRAZYME PLUS GPT

Applicant Harleco Diagnostics

K number K821882

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CKA 1982-07-02

PYRIDOXAL-5-PHOSPHATE STRIPES

Applicant Boehringer Mannheim Corp.

K number K821805

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CKA 1982-06-14

DOWFLOW ALT-UV DETERMINATION

Applicant The Dow Chemical Co.

K number K821536

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CKA 1982-05-03

LIQUID-STAT TM AST-UV LIQUID ENZUNE

Applicant Beckman Instruments, Inc.

K number K821048

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CKA 1982-03-15

RAICHEM GPT (ALT) REAGENT

Applicant Reagents Applications, Inc.

K number K820525

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CKA 1982-03-08

TECHNICON RA-1000 SYSTEM ADD. ANALYT

Applicant Technicon Instruments Corp.

K number K820394

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CKA 1981-12-31

ALT (SGPT)

Applicant Pointe Scientific, Inc.,

K number K813495

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CKA 1981-11-06

ALT-QUANTICHROM

Applicant Abbott Laboratories

K number K812926

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CKA 1981-09-24

ULTRA ZYME PLUS GPT, #64956, 65035 & 36

Applicant Harleco

K number K812591

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CKA 1981-07-01

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT

Applicant Baker Instructions Corp.

K number K811694

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