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 1984-08-23

TANDEM FAST VISUAL HCG ASSAY KIT -

Applicant Hybritech, Inc.

K number K842633

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JHI 1984-07-26

STAR HCG MONOCLONAL ANTIBODY IMMUNO

Applicant Syncor Intl. Corp.

K number K842598

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JHI 1984-06-22

BHCG RIA

Applicant Syncor Intl. Corp.

K number K841854

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JHI 1984-06-22

CA-1511, IN VITRO RADIOIMMUNOASSAY

Applicant Travenol Laboratories, S.A.

K number K841821

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JHI 1984-06-05

OREIA II B-HCG PREGNANCY TEST KIT

Applicant Organon, Inc.

K number K841525

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JHI 1984-05-07

VENTREZYME BETA-HCG IMMUNOASSAY HCG

Applicant Ventrex Laboratories, Inc.

K number K841081

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JHI 1984-05-01

COATED TUBE HCG IMMUNOASSAY HCG

Applicant Ventrex Laboratories, Inc.

K number K841023

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JHI 1984-04-19

PHASE II HCG KIT

Applicant Medical & Scientific Designs, Inc.

K number K840328

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JHI 1984-03-19

HCG RIA

Applicant Syncor Intl. Corp.

K number K833851

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JHI 1984-02-03

TANDEM VISUAL HCG IMMUNOENZYMETRIC

Applicant Hybritech, Inc.

K number K834000

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JHI 1984-02-03

VENTREX PREGNANCY TEST KIT ENZYME

Applicant Vxr, Inc.

K number K833960

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JHI 1984-01-24

STAR HCG MONOCLONAL ANTIBODY IMMUNORAD

Applicant Syncor Intl. Corp.

K number K832796

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JHI 1984-01-18

TANDEM R-TOTAL B-GCG KIT

Applicant Hybritech, Inc.

K number K833194

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JHI 1983-12-08

OREIA II B-HCG, ENZYME INNUNOASSAY

Applicant Organon, Inc.

K number K832801

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JHI 1983-10-28

MODIFIED CHORIO-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K number K832892

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JHI 1983-09-12

SERUM HCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K832562

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JHI 1983-07-19

HCG ACCU-STICK

Applicant Btc Diagnostics, Inc.

K number K831604

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JHI 1983-06-08

PBI BHCG RIA KIT

Applicant Pacific Biotech, Inc.

K number K831302

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JHI 1983-06-08

BHCG RIA KIT

Applicant Micromedic Systems

K number K831264

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JHI 1983-06-02

BETA-QUIK-15 RIA KIT

Applicant Pacific Biotech, Inc.

K number K831223

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JHI 1983-06-02

RIAGEN B-HCG RIA KIT

Applicant Biogenex Laboratories

K number K831221

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JHI 1983-06-02

DUOCLON SLIDE TEST

Applicant Organon, Inc.

K number K831109

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JHI 1983-06-02

ARIA II I-HCG

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K830997

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JHI 1983-04-05

B-GCG SYSTEM BY RIA

Applicant Pcl-Ria, Inc.

K number K830526

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JHI 1983-03-29

BETA-COTE B-HCG PREGNANCY SCREENING SYS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K830695

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JHI 1983-02-18

DAC-CEL DIAGNATAL RD 50

Applicant Wellcome Diagnostics

K number K830203

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JHI 1983-02-07

TANDEM E GCG VISUAL END POINT INNUMOENZ

Applicant Hybritech, Inc.

K number K830138

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JHI 1983-01-24

GENESIS B-HCG

Applicant Armkel, LLC

K number K823753

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JHI 1982-12-22

IN VITRO GAMMACOAT B-HCG RADIO. TEST

Applicant Clinical Assays, Inc.

K number K823313

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JHI 1982-10-27

RADIOIMMUNOASSAY, HUMAN CHORRIONIC

Applicant Bioclinical Group

K number K822840

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JHI 1982-09-28

MODEL UCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K822520

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JHI 1982-09-14

B-HCG RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K822515

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JHI 1982-09-02

B-HCG

Applicant Diagnostic Products Corp.

K number K822343

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JHI 1982-09-02

HCG BETA RIA KIT

Applicant Clinetics Corp.

K number K822152

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JHI 1982-07-22

TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K821944

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JHI 1982-07-13

RIAGEN B-HCG RIA

Applicant Biogenex Laboratories

K number K821657

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JHI 1982-05-21

RIAGEN B-HCG RIA

Applicant Biogenex Laboratories

K number K821234

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JHI 1982-05-03

AMERLEX B-LCG RIA KIT

Applicant Amersham Corp.

K number K821031

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JHI 1982-05-03

ROCHE(R) B-HCG RIA URINE STANDARD

Applicant Hoffmann-La Roche, Inc.

K number K820942

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JHI 1982-04-29

TANDEM HCG KIT

Applicant Hybritech, Inc.

K number K820822

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JHI 1982-04-01

ROCHE B-HCG STANDARDS

Applicant Hoffmann-La Roche, Inc.

K number K820614

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JHI 1982-04-01

ROCHE B-HCG RIA

Applicant Hoffmann-La Roche, Inc.

K number K820613

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JHI 1982-03-15

CHORIO-QUANT

Applicant Nuclear Medical Laboratories, Inc.

K number K820523

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JHI 1982-03-11

IMMOPHASE B HCG RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K820321

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JHI 1982-03-11

ABBOTT LABORATORIES B-HCG EIA

Applicant Abbott Laboratories

K number K820271

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JHI 1981-10-13

TANDEM QUALITATIVE HCG KIT

Applicant Hybritech, Inc.

K number K812461

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JHI 1981-08-20

CONCEP-7-BHCG

Applicant Leeco Diagnostics, Inc.

K number K812156

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JHI 1981-07-10

HCG RADIOIMMUNOASSAY KIT (125I)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K811421

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JHI 1981-05-29

EARLY PREGNANCY DETECTION

Applicant Immuchem Corp.

K number K811398

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JHI 1981-05-13

HCG RADIOIMMUNOASSAY

Applicant Hoffmann-La Roche, Inc.

K number K811116

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JHI 1981-04-17

CHORIO-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K number K810936

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JHI 1981-04-17

DAC-CEL HCG

Applicant Burroughs Wellcome Co.

K number K810215

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JHI 1981-03-06

DAC-CEL DIAGNATAL

Applicant Burroughs Wellcome Co.

K number K810214

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JHI 1980-12-22

BETA-TEC QUALITATIVE

Applicant Armkel, LLC

K number K802999

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JHI 1980-08-13

MRI HCG-BETA RIA KIT CAT. #MR-10100

Applicant Microanalytic Research, Inc.

K number K801491

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JHI 1980-07-14

GAMMADAB B-HCG RADIOIMMUNOASSAY KIT

Applicant Travenol Laboratories, S.A.

K number K801409

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JHI 1980-06-20

ROCHE HCG STANDARDS

Applicant Hoffmann-La Roche, Inc.

K number K801244

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JHI 1979-12-06

CONCEP-7-BHCG

Applicant Leeco Diagnostics, Inc.

K number K792308

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JHI 1979-12-06

HUMAN CHORIONIC GONADOTROPIN (RIA)

Applicant Nuclear Medical Laboratories, Inc.

K number K792197

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JHI 1979-07-30

HCG RIA PREGNANCY TEST

Applicant Hoffmann-La Roche, Inc.

K number K791206

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JHI 1979-07-17

LABELED HUMAN CHORIONIC GONADOTROPHIN

Applicant Pcl-Ria, Inc.

K number K790876

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JHI 1979-07-17

RABBIT ANTISERUM TO HUMAN CHORIONIC

Applicant Pcl-Ria, Inc.

K number K790864

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JHI 1979-07-17

HUMAN CHORIONIC GONADOTROPHIN STANDARDS

Applicant Pcl-Ria, Inc.

K number K790863

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JHI 1979-05-23

CONCEP-7-B-HCG

Applicant Leeco Diagnostics, Inc.

K number K790397

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JHI 1979-03-12

CHORIC-SHURE

Applicant Nuclear Medical Laboratories, Inc.

K number K790138

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JHI 1978-12-29

BETA-TEC

Applicant Wampole Laboratories

K number K781794

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JHI 1978-12-20

RIA KIT, PREG-STAT

Applicant Serono Laboratories, Inc.

K number K781733

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JHI 1978-10-11

EARLY PREGNANCY DETECTION KIT

Applicant Radioassay Systems Laboratories, Inc.

K number K781487

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JHI 1978-10-10

RIA QUANT B-HCG TEST KIT

Applicant Mallinckrodt Critical Care

K number K781578

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JHI 1978-08-31

HUMAN CHORIONIC GONADO.-BETA RIA KIT

Applicant Diagnostics Biochem Canada, Inc.

K number K781310

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JHI 1978-06-14

B-HCG-RIA

Applicant Nuclear Medical Systems, Inc.

K number K780679

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JHI 1977-11-23

QUANTROLS HCG

Applicant Organon, Inc.

K number K772086

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JHI 1977-11-23

BETA-HCG RIA

Applicant Monitor Science Corp.

K number K772039

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JHI 1976-11-12

BIOCEPT-G

Applicant Wampole Laboratories

K number K760336

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