Visual, Pregnancy Hcg, Prescription Use

FDA product code JHI · 374 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1155
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-12 – 2026-09-22

JHI 1989-12-01

MILENIA(TM) HCG (MKCG1,5)

Applicant Diagnostic Products Corp.

K number K895809

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JHI 1989-11-13

CARDS O.S. (TM) HCG-URINE

Applicant Pacific Biotech, Inc.

K number K895390

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JHI 1989-10-25

COAT-A-COUNT (TM) HCG IRMA

Applicant Diagnostic Products Corp.

K number K894941

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JHI 1989-10-25

QUIDEL HCG TEST

Applicant Quidel Corp.

K number K894790

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JHI 1989-10-18

BIOSTIX I. HCG - ONE STEP PREGNANCY TEST

Applicant Princeton Biomedix

K number K894750

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JHI 1989-10-18

BIOSPOT HCG-RAPID PREGNANCY TEST

Applicant Princeton Biomedix

K number K894705

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JHI 1989-10-04

ORTHO RESULT PLUS/PREGNANCY

Applicant Ortho Diagnostic Systems, Inc.

K number K894420

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JHI 1989-09-26

IMX TOTAL B-HCG

Applicant Abbott Laboratories

K number K894182

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JHI 1989-09-05

ABBOTT TESTPACK PLUS HCG URINE

Applicant Abbott Laboratories

K number K894408

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JHI 1989-07-25

MINICLINIC PREGNANCY TEST

Applicant Vanguard Biomedical Corp.

K number K894012

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JHI 1989-05-24

HCG IRMA II

Applicant Pacific Biotech, Inc.

K number K891770

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JHI 1989-04-18

DIRECTIGEN1-2-3 BHCG PREGNANCY TEST

Applicant Quidel Corp.

K number K890615

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JHI 1989-03-28

VENTREX COATED TUBE HCG

Applicant Ventrex Laboratories, Inc.

K number K890549

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JHI 1989-03-09

TARGET(TM) QUANTITATIVE HCG

Applicant V-Tech, Inc.

K number K890131

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JHI 1989-01-13

PREGNAGEN(TM)

Applicant Biogenex Laboratories

K number K884880

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JHI 1989-01-13

FIRSTDAY EARLY PREGNANCY TESTING KIT II

Applicant Pacific Biotech, Inc.

K number K884616

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JHI 1988-10-13

CIBA CORNING MAGIC LITE HCG IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K883927

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JHI 1988-10-06

CLEARVIEW HCG

Applicant Unipath , Ltd.

K number K883777

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JHI 1988-10-06

MODIFIED HCG IRMA KIT

Applicant Pacific Biotech, Inc.

K number K883639

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JHI 1988-09-09

PREGNAGEN(TM)

Applicant Biogenex Laboratories

K number K882002

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JHI 1988-08-29

FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT

Applicant Pacific Biotech, Inc.

K number K881015

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JHI 1988-08-08

COTUBE HCG IRMA TEST

Applicant Bio-Rad

K number K882155

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JHI 1988-08-02

QLT ABSOLUTE URINE-HCG PREGNANCY TEST

Applicant Quadra Logic Technologies, Inc.

K number K881806

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JHI 1988-07-28

QTEST(TM) PREGNANCY

Applicant Quidel Corp.

K number K882086

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JHI 1988-07-08

IMMUNOCARD(TM) HCG II TEST KIT

Applicant Disease Detection International, Inc.

K number K881709

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JHI 1988-06-08

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT

Applicant Amersham Corp.

K number K881355

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JHI 1988-05-27

QUIDEL PREGNANCY TEST

Applicant Quidel Corp.

K number K881595

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JHI 1988-05-27

IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG

Applicant Icn Biomedicals, Inc.

K number K881005

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JHI 1988-04-05

HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT

Applicant Disease Detection International, Inc.

K number K880410

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JHI 1988-03-24

ABBOTT IMX HCG

Applicant Abbott Laboratories

K number K880070

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JHI 1988-03-15

CONCEP-7-BHCG

Applicant Leeco Diagnostics, Inc.

K number K880577

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JHI 1988-02-08

KODAK SURECELL(TM) HCG-URINE KIT

Applicant Eastman Kodak Company

K number K874388

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JHI 1988-01-05

IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X

Applicant Diagnostic Products Corp.

K number K874033

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JHI 1987-11-23

VENTRESCREEN, HCG URINE

Applicant Ventrex Laboratories, Inc.

K number K874258

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JHI 1987-11-23

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504

Applicant Pacific Biotech, Inc.

K number K873788

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JHI 1987-10-20

RESULT PLUS/HCG PREGNANCY TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K872730

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JHI 1987-10-06

AFFINITY HCG IMMUNIT (POLYCLONAL)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K873524

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JHI 1987-09-14

HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE

Applicant Serono Diagnostics, Inc.

K number K873033

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JHI 1987-09-02

ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM

Applicant Nichols Institute Diagnostics

K number K872390

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JHI 1987-08-05

BINAX IRMA TOTAL BETA-HCG TEST KIT

Applicant Binax, Inc.

K number K872728

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JHI 1987-07-16

ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES

Applicant Syva Co.

K number K872130

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JHI 1987-07-15

HCG MAB SOLID PHASE COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K871700

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JHI 1987-06-11

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT

Applicant Allelix, Inc.

K number K871308

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JHI 1987-06-03

TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT

Applicant Hybritech, Inc.

K number K871235

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JHI 1987-05-28

AFFINITY (TM) HCG IMMUNIT (TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K870627

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JHI 1987-05-20

SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST

Applicant Syntron Bioresearch, Inc.

K number K870751

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JHI 1987-05-20

ABBOTT TESTPACK HCG COMBO

Applicant Abbott Laboratories

K number K870739

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JHI 1987-04-08

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY

Applicant Hybritech, Inc.

K number K870521

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JHI 1987-04-01

ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K870672

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JHI 1987-03-13

COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS

Applicant Diagnostic Products Corp.

K number K870106

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JHI 1987-03-13

UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE

Applicant United Biotech, Inc.

K number K864174

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JHI 1987-03-10

VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044

Applicant Leeco Diagnostics, Inc.

K number K870259

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JHI 1987-03-10

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K865057

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JHI 1987-02-11

SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST

Applicant Syntron Bioresearch, Inc.

K number K865076

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JHI 1987-02-04

HCG SOLID PHASE COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K864591

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JHI 1986-12-15

VIS-CUBE HCG (EIA)

Applicant Leeco Diagnostics, Inc.

K number K863933

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JHI 1986-11-21

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA

Applicant Hybritech, Inc.

K number K863861

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JHI 1986-09-15

CARDS(TM) HCG-URINE

Applicant Pacific Biotech, Inc.

K number K863199

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JHI 1986-09-15

ABBOTT TESTPACK (TM) HCG SERUM

Applicant Abbott Laboratories

K number K863032

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JHI 1986-07-29

HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS

Applicant Serono Diagnostics, Inc.

K number K862262

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JHI 1986-07-29

TARGET HCG, ENZYME IMMUNOASSAY REAGENTS

Applicant V-Tech, Inc.

K number K862247

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JHI 1986-07-01

HCG IRMA, CAT. NO. CR-1501

Applicant Pacific Biotech, Inc.

K number K862007

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JHI 1986-04-24

BETA QUIK STICK

Applicant Pacific Biotech, Inc.

K number K860965

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JHI 1986-03-05

TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K860542

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JHI 1986-03-05

MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY

Applicant Medix Biotech, Inc.

K number K860490

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JHI 1986-01-28

HCG RIA TEST SYSTEM

Applicant Monobind

K number K854958

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JHI 1986-01-13

CANWEST-PREGBLUE

Applicant Canwest Medictex, Inc.

K number K854989

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JHI 1986-01-13

MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO

Applicant Bioclinical Systems, Inc.

K number K854059

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JHI 1985-12-30

RAMP URINE HCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K854611

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JHI 1985-12-05

IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)

Applicant Immunchem Corp.

K number K854104

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JHI 1985-12-05

LBK 1244 DELFIA HCG KIT

Applicant Lkb Instruments, Inc.

K number K852760

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JHI 1985-12-02

QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA

Applicant Nms Pharmaceuticals, Inc.

K number K853925

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JHI 1985-11-26

CORNING MAGIC MAB HCG RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K854024

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JHI 1985-10-01

VENTRESCREEN HCG URINE

Applicant Vxr, Inc.

K number K853748

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JHI 1985-10-01

BETA-HCG MICROTITER PREGNANCY TEST

Applicant Modern Diagnostics, Inc.

K number K853258

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JHI 1985-09-25

ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K853539

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JHI 1985-09-04

HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY

Applicant Modern Diagnostics, Inc.

K number K853006

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JHI 1985-08-20

BETA QUIK STAT

Applicant Pacific Biotech, Inc.

K number K852327

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JHI 1985-07-22

AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT

Applicant Amersham Corp.

K number K852675

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JHI 1985-07-12

VISUAL SERUM/URINE HCG COMBO KIT

Applicant American Bioclinical, Inc.

K number K852437

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JHI 1985-07-09

BETA HCG EXTENDED RANGE ACCESSORY KIT

Applicant Abbott Laboratories

K number K852183

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JHI 1985-06-28

ECHOCLONAL HCG IRMA

Applicant Bio-Rad

K number K852201

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JHI 1985-06-25

BHCG-ROCHE EIA

Applicant Hoffmann-La Roche, Inc.

K number K850727

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JHI 1985-05-10

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST

Applicant United Biotech, Inc.

K number K851076

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JHI 1985-05-01

PREGNA-ZYME

Applicant Armkel, LLC

K number K850992

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JHI 1985-04-12

MEDIX VISUAL URINE HCG (7/7) TEST

Applicant Medix Biotech, Inc.

K number K850949

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JHI 1985-04-08

MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM

Applicant Medix Biotech, Inc.

K number K850987

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JHI 1985-04-02

MODEL SERUM HCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K850730

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JHI 1985-04-02

STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K850570

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JHI 1985-04-02

LEECO CONCEP-7-BHCG EIA

Applicant Leeco Diagnostics, Inc.

K number K850531

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JHI 1985-04-02

LEECO CONCEP-7-BHCG IRMA

Applicant Leeco Diagnostics, Inc.

K number K850530

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JHI 1985-03-04

LEECO CONCEP-7-BHCG LEIAD II

Applicant Leeco Diagnostics, Inc.

K number K850201

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JHI 1985-03-04

TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K850159

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JHI 1984-12-14

CONCEP-7-BHCG (EIA)

Applicant Leeco Diagnostics, Inc.

K number K844153

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JHI 1984-11-21

QUEST BETA HCG ENZYME IMMUNOASSAY KIT

Applicant Quidel Corp.

K number K844082

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JHI 1984-10-30

BETA QUIK V

Applicant Pacific Biotech, Inc.

K number K843795

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JHI 1984-10-04

ENCORE HCG REAGENT

Applicant Hybritech, Inc.

K number K843407

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JHI 1984-10-01

EPSILON HCG TEST KIT MONOCLONAL

Applicant Beckman Instruments, Inc.

K number K842654

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JHI 1984-09-14

NMS 1043 ENZYME IMMUNOASSAY KIT

Applicant Nms Pharmaceuticals, Inc.

K number K842499

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JHI 1984-09-05

QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT

Applicant Quidel Corp.

K number K842692

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