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 1997-02-11

ONE-STEP DIPSTICK PREGNANCY TEST

Applicant Teco Diagnostics

K number K964536

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JHI 1997-02-11

ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST

Applicant Teco Diagnostics

K number K964462

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JHI 1997-02-11

ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST

Applicant Teco Diagnostics

K number K964461

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JHI 1997-02-04

OSOM CLASSIC HCG-URINE TEST (115)

Applicant Wyntek Diagnostics, Inc.

K number K965227

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JHI 1997-01-21

SAS ONE-STEP PREGNANCY

Applicant Sa Scientific, Inc.

K number K964995

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JHI 1997-01-21

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

Applicant Athena Medical Corp.

K number K964574

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JHI 1996-12-04

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

Applicant Excel Scientific, Inc.

K number K963231

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JHI 1996-11-25

CONTRAST STRIP HCG

Applicant Genzyme Diagnostics

K number K964156

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JHI 1996-11-25

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

Applicant Genzyme Diagnostics

K number K964155

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JHI 1996-11-18

PS-UNIT CASSETTE/SERUM HCG

Applicant International Newtech Development, Inc.

K number K963133

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JHI 1996-11-18

MINI STRIP/SERUM HCG

Applicant International Newtech Development, Inc.

K number K963132

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JHI 1996-10-18

VISUALINE D HCG

Applicant Sun Biomedical Laboratories, Inc.

K number K963408

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JHI 1996-08-23

SCRIPPS LABORATORIES HCG ONE-STEP

Applicant Scripps Laboratories, Inc.

K number K962906

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JHI 1996-07-10

BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

Applicant Biochem Immunosystems (U.S.), Inc.

K number K954065

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JHI 1996-06-28

DSL ACTIVE I-HCG ELISA

Applicant Diagnostic Systems Laboratories, Inc.

K number K961911

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JHI 1996-05-07

DSL ACTIVE I-HCG IRMA

Applicant Diagnostic Systems Laboratories, Inc.

K number K960357

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JHI 1996-04-25

BIONIKE A/Q PREGNANCY TEST

Applicant Bionike Laboratories, Inc.

K number K960992

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JHI 1996-03-19

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT

Applicant Tcpi, Inc.

K number K955353

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JHI 1996-02-29

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT

Applicant Boehringer Mannheim Italia Spa

K number K955266

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JHI 1995-12-21

MIT ONE STEP PREGNANCY TEST

Applicant 3c Diagnostics, Inc.

K number K953486

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JHI 1995-12-13

QUIX RAPID PREGNANCY STRIP TEST

Applicant Guardian Scientific, Corp.

K number K954993

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JHI 1995-12-11

BIONIKE A/Q PREGNANCY TEST

Applicant Bionike Laboratories, Inc.

K number K954901

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JHI 1995-11-20

ACCESS TOTAL BHCG ASSAY (MODIFICATION)

Applicant Bio-Rad Laboratories, Inc.

K number K954732

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JHI 1995-10-16

CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG

Applicant Quidel Corp.

K number K954273

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JHI 1995-10-05

TESTPACK PLUS HCG URINE

Applicant Abbott Laboratories

K number K954029

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JHI 1995-10-03

MINISTRIP HCG

Applicant International Newtech Development, Inc.

K number K951705

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JHI 1995-08-29

WYNTEK OSOM HCG-URINE TEST

Applicant Wyntek Diagnostics, Inc.

K number K953383

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JHI 1995-06-20

CONTRAST & RAPID HCG URINE/SERUM TST

Applicant Medix Biotech, Inc.

K number K952319

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JHI 1995-04-20

BIONIKE A/Q PREGNANCY TEST

Applicant Charlton Assoc.

K number K951136

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JHI 1995-02-10

QUICK CHECKER HCG PREGNANCY TEST

Applicant Mizuho USA, Inc.

K number K943859

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JHI 1995-02-08

QUIKPAC II, ONE STEP HCG COMBO KIT

Applicant Syntron Bioresearch, Inc.

K number K945951

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JHI 1995-01-27

RAPIDVUE(TM) HCG

Applicant Quidel Corp.

K number K945969

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JHI 1994-12-07

VISUALINE II HCG

Applicant Sun Biomedical Laboratories, Inc.

K number K943239

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JHI 1994-10-25

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE

Applicant Princeton BioMeditech Corp.

K number K944426

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JHI 1994-09-20

UC QIK 1-STEP HCG TEST

Applicant Eucardio Laboratory, Inc.

K number K942464

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JHI 1994-06-21

AXSYM TOTAL B-HCG

Applicant Abbott Laboratories

K number K935673

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JHI 1994-04-15

ONE STEP PREGNANCY TEST

Applicant Teco Diagnostics

K number K936031

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JHI 1994-04-08

KODAK SURECELL HCG URINE TEST, MODIFICATION

Applicant Eastman Kodak Company

K number K936287

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JHI 1994-04-08

KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION

Applicant Eastman Kodak Company

K number K936138

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JHI 1994-01-27

EVENT TEST STRIP HCG

Applicant Boehringer Mannheim Italia Spa

K number K935502

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JHI 1993-11-05

KINGS BAY PRELUDE ONE STEP HCG COMBO KIT

Applicant King'S Bay Intl., Inc.

K number K931698

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JHI 1993-09-28

MEDIX BIOTECH BESTEST HCG-URINE TEST KIT

Applicant Medix Biotech, Inc.

K number K932758

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JHI 1993-07-08

OPUS(R) TOTAL B-HCG TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K932279

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JHI 1993-06-29

QUICKVUE ONE-STEP HCG COMBO

Applicant Quidel Corp.

K number K932042

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JHI 1993-06-15

PRO-STEP PT HCG

Applicant Disease Detection International, Inc.

K number K925303

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JHI 1993-06-09

SAS PREGNANCY STRIP

Applicant Sa Scientific, Inc.

K number K931302

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JHI 1993-06-07

UC QIK PREGNANCY TEST

Applicant Eucardio Laboratory, Inc.

K number K926500

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JHI 1993-05-11

CLEARVIEW HCG

Applicant Unipath , Ltd.

K number K924673

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JHI 1993-03-25

PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST

Applicant Vanguard Biomedical Corp.

K number K930014

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JHI 1993-03-19

CIBA CORNING ACS HCG IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K925277

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JHI 1993-03-18

PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG

Applicant Becton Dickinson Advanced Diagnostics

K number K926356

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JHI 1993-02-17

VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY

Applicant Syva Co.

K number K926342

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JHI 1993-02-08

ACCESS TOTAL BHCG ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K926198

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JHI 1993-02-02

SAS ONE STEP PREGNANCY

Applicant Sa Scientific, Inc.

K number K926204

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JHI 1993-01-13

PRO-STEP HCG

Applicant Disease Detection International, Inc.

K number K925125

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JHI 1992-12-24

HCG STAT-PAK

Applicant Chembio Diagnostic Systems, Inc.

K number K923925

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JHI 1992-12-03

QUICKVUE ONE-STEP HCG TEST

Applicant Quidel Corp.

K number K925435

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JHI 1992-11-25

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

Applicant Medix Biotech, Inc.

K number K924259

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JHI 1992-10-01

VISUAL HCG PREGNANCY TEST

Applicant Tech-Co, Inc.

K number K923376

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JHI 1992-09-15

ANI BIOCARD HCG TEST

Applicant Ani OY

K number K923030

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JHI 1992-09-09

HCG PREGNANCY ONE STEP TEST STRIP

Applicant Tcpi, Inc.

K number K923123

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JHI 1992-08-10

DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD

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

K number K922697

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JHI 1992-07-28

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Applicant Vitek Systems, Inc.

K number K921302

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JHI 1992-07-09

SINGLE-STEP PREGNANCY, HCG TEST

Applicant American Medical Products, Inc.

K number K922290

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JHI 1992-05-07

MIRCO ELISA HPL TEST KIT

Applicant Bio Clinic Co.

K number K921212

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JHI 1992-05-07

NOW PREGNANCY TEST KIT

Applicant Bio Clinic Co.

K number K921211

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JHI 1992-04-07

TMB CHROMOGEN/SUBSTRATE REAGENT SET

Applicant Bio Clinic Co.

K number K920918

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JHI 1992-03-23

AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR

Applicant Eastman Kodak Company

K number K920505

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JHI 1992-02-14

MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K920253

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JHI 1992-01-27

KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION

Applicant Eastman Kodak Company

K number K915701

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JHI 1991-12-17

PRECISE TM HCG

Applicant Becton Dickinson Advanced Diagnostics

K number K915197

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JHI 1991-12-16

PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA

Applicant Becton Dickinson Advanced Diagnostics

K number K915200

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JHI 1991-11-13

MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011

Applicant Medix Biotech, Inc.

K number K914696

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JHI 1991-10-25

CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF

Applicant Unipath , Ltd.

K number K914240

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JHI 1991-10-11

TARGET(TM)-HOG

Applicant V-Tech, Inc.

K number K914303

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JHI 1991-10-11

PROCLINIC ONE STEP PREGNANCY TEST

Applicant Vanguard Biomedical Corp.

K number K914253

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JHI 1991-08-16

DIRECTIGEN 1-2-3(TM) HCG TEST

Applicant Quidel Corp.

K number K913122

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JHI 1991-07-19

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT

Applicant Disease Detection International, Inc.

K number K911826

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JHI 1991-07-01

IMX TOTAL B-HCG

Applicant Abbott Laboratories

K number K912535

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JHI 1991-07-01

IMX HCG

Applicant Abbott Laboratories

K number K912534

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JHI 1991-06-24

OBA(TM) SERUM HCG ASSAY

Applicant Adeza Biomedical

K number K911047

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JHI 1991-05-15

CLEARVIEW HCG SERUM/URINE

Applicant Unipath , Ltd.

K number K905741

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JHI 1991-03-21

IMMUNOCORP COATED TUBE IRMA HCG

Applicant Immunocorp

K number K910349

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JHI 1991-02-26

BIOCLONE'S ELEGANCE HCG ELISA KIT

Applicant Bioclone Australia Pty , Ltd.

K number K910420

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JHI 1990-10-22

TARGET(TM) HOG ONE STEP

Applicant V-Tech, Inc.

K number K903937

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JHI 1990-10-15

MAXI TEST

Applicant Bhc Biotech , Ltd.

K number K904016

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JHI 1990-10-03

CIBA CORNING ACS HCG IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K904123

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JHI 1990-09-25

ABBOTT TESTPACK PLUS TM HCG-COMBO

Applicant Abbott Laboratories

K number K903219

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JHI 1990-08-09

AFFINITY HCG TEST SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K902720

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JHI 1990-08-09

EZ-SCREEN:HCG

Applicant Environmental Diagnostics, Inc.

K number K902681

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JHI 1990-06-28

KODAK SURECELL(TM) HCG-URINE TEST KIT

Applicant Eastman Kodak Company

K number K902136

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JHI 1990-06-26

OPUS (TM) HCG

Applicant Pb Diagnostic Systems, Inc.

K number K901935

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JHI 1990-05-04

BIOSIGN HCG-ONE STEP PREGNANCY TEST

Applicant Princeton Biomedix

K number K901011

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JHI 1990-05-01

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

Applicant London Diagnostics, Inc.

K number K901484

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JHI 1990-04-18

IMX HCG (LIST #03A63)

Applicant Abbott Laboratories

K number K900327

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JHI 1990-03-29

HCG SOLID PHASE COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K901045

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JHI 1990-02-16

MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K896587

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JHI 1990-02-08

ENZYMUN TEST R HCG

Applicant Boehringer Mannheim Corp.

K number K896901

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JHI 1989-12-19

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K894175

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JHI 1989-12-01

IMMUNOCARD HCG II-S TEST KIT

Applicant Disease Detection International, Inc.

K number K895912

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