Enzyme Immunoassay, Cannabinoids

FDA product code LDJ · 145 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3870
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-08-20 – 2024-01-17

LDJ 1992-02-27

CANNABINOID EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K920311

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LDJ 1992-01-22

MICROLINE SCREEN FOR CANNABINOID

Applicant Drug Screening Systems, Inc.

K number K914915

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LDJ 1991-11-29

MICRO EIA FOR MARIJUANA METABOLITES

Applicant Microdiagnostics, Inc.

K number K914490

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LDJ 1991-07-26

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS

Applicant Roche Diagnostic Systems, Inc.

K number K912757

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LDJ 1991-06-21

ABUSCREEN FP FOR CANNABINOIDS (15-50)

Applicant Roche Diagnostic Systems, Inc.

K number K910592

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LDJ 1991-04-03

TARGET(TM) CANNABINOIDS-R TEST

Applicant V-Tech, Inc.

K number K910893

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LDJ 1991-04-03

TARGET(TM) CANNABINOIDS-V TEST

Applicant V-Tech, Inc.

K number K910892

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LDJ 1991-04-03

ABUSCREEN FP FOR CANNABINOIDS (50-100)

Applicant Roche Diagnostic Systems, Inc.

K number K910589

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LDJ 1990-12-26

EMIT(R) II CANNABINOID 50 NG ASSAY

Applicant Syva Co.

K number K904571

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LDJ 1990-12-26

EMIT(R) II CANNABINOID 20 NG ASSAY

Applicant Syva Co.

K number K904570

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LDJ 1990-12-26

EMIT(R) II CANNABINOID 100 NG ASSAY

Applicant Syva Co.

K number K904568

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LDJ 1990-12-13

ABUSCREEN ONTRAK FOR THC

Applicant Roche Diagnostic Systems, Inc.

K number K904856

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LDJ 1990-11-20

LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS

Applicant Abbott Laboratories

K number K904541

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LDJ 1990-11-01

MICROZYME THC ENZYME IMMUNOASSAY TEST KIT

Applicant Immunotech Corp.

K number K904635

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LDJ 1990-05-17

MILENIA(TM) CANNABINOIDS

Applicant Diagnostic Products Corp.

K number K901568

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LDJ 1990-05-14

HYCOR ACCUPINCH THC TEST

Applicant Hycor Biomedical, Inc.

K number K901334

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LDJ 1989-08-25

ADX CANNABINOIDS

Applicant Abbott Laboratories

K number K890693

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LDJ 1989-04-10

CRACK-IT CANNABINOID SCREEN

Applicant Sakers, Inc.

K number K874390

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LDJ 1989-03-16

ABUSCREEN FP FOR CANNABINOIDS

Applicant Roche Diagnostic Systems, Inc.

K number K890887

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LDJ 1988-10-11

TDX CANNABINOIDS-GS

Applicant Abbott Laboratories

K number K883731

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LDJ 1988-08-29

EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS

Applicant Syva Co.

K number K882313

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LDJ 1988-08-08

EMIT HVA CANNABINOID 100 NG ASSAY

Applicant Syva Co.

K number K882819

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LDJ 1988-07-29

ABUSCREEN(R) ONTRAK(TM) FOR THC

Applicant Roche Diagnostic Systems, Inc.

K number K881814

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LDJ 1988-06-24

MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN

Applicant Keystone Diagnostics, Inc.

K number K875219

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LDJ 1988-06-22

STAT FIX MICROWAVE IRRADIATION MEDIUM

Applicant Stat Path

K number K882362

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LDJ 1988-03-01

REVISED LABELING FOR ADX CANNABINOIDS

Applicant Abbott Laboratories

K number K880015

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LDJ 1988-02-03

ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH

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

K number K875252

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LDJ 1987-12-18

TDXR DELTA-9-CANNABINOIDS

Applicant Abbott Laboratories

K number K874646

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LDJ 1987-11-23

REVISED LABELING FOR TDX CANNABINOIDS

Applicant Abbott Laboratories

K number K874488

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LDJ 1987-11-20

REVISED LABELING FOR CANNABINOIDS TEST KIT

Applicant Roche Diagnostic Systems, Inc.

K number K874269

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LDJ 1987-11-03

CANNABINOID ENZYME IMMUNOASSAY KIT

Applicant General Diagnostics

K number K872882

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LDJ 1987-10-28

STICKER LABEL FOR DRUGS OF ABUSE ASSAYS

Applicant Syva Co.

K number K874156

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LDJ 1987-10-28

REVISED LABELING FOR SYVA CANNABINOID ASSAYS

Applicant Syva Co.

K number K874079

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LDJ 1987-10-15

LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE

Applicant Diagnostic Products Corp.

K number K873753

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LDJ 1987-06-05

DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5

Applicant Diagnostic Products Corp.

K number K871695

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LDJ 1987-06-01

KDI QUIK TEST(TM) MARIJUANA SCREEN

Applicant Keystone Diagnostics, Inc.

K number K870197

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LDJ 1987-03-16

ABUSCREEN (R) EIA CANNABINOIDS

Applicant Roche Diagnostic Systems, Inc.

K number K870377

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LDJ 1987-03-13

TDXR CANNABINOIDS

Applicant Abbott Laboratories

K number K864751

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LDJ 1986-04-11

EMIT D.A.U. CANNABINOID 20NG ASSAY

Applicant Syva Co.

K number K860500

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LDJ 1985-05-01

EMIT 700 CANNABINOID 20 ASSAY

Applicant Syva Co.

K number K851373

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LDJ 1984-09-25

EMIT 700 CANNABINOID ASSAY

Applicant Syva Co.

K number K843421

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LDJ 1984-06-21

EMIT ST URINE CANNABINOID ASSAY

Applicant Syva Co.

K number K841238

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LDJ 1984-06-21

EMIT D.A.U. URINE CANNABINOID ASSAY

Applicant Syva Co.

K number K834458

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LDJ 1984-01-26

MODIF. OF EMIT URINE CANNABINOID

Applicant Syva Co.

K number K833580

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LDJ 1981-08-20

EMIT-ST CANNABINOID ASSAY

Applicant Syva Co.

K number K812195

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