Product code JXM
- Device name
- Enzyme Immunoassay, Benzodiazepine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3170
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | 2024-12-11 |
| K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | 2022-12-23 |
| K190968 | CEDIA Benzodiazepine Assay | Microgenics Corporation | 2019-12-09 |
| K173963 | DRI Benzodiazepine Assay | Microgenics Corporation | 2018-02-21 |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | Psychemedics Corporation | 2017-09-15 |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2017-08-02 |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2016-05-23 |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2016-01-05 |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015-08-13 |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015-05-13 |
| K123080 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | Chemtron Biotech, Inc. | 2012-11-29 |
| K111322 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | Chemtron Biotech, Inc. | 2011-09-14 |
| K092274 | RANDOX BENZODIAZEPINE ASSAY | Randox Laboratories, Ltd. | 2010-10-15 |
| K062285 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | Acro Biotech, LLC | 2006-07-28 |
| K051307 | SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT | Beckman Coulter, Inc. | 2005-06-13 |
| K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY | Randox Laboratories, Ltd. | 2005-05-17 |
| K043556 | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT | Beckman Coulter, Inc. | 2005-03-28 |
| K043327 | ONLINE DAT BENZODIAZEPINES PLUS | Roche Diagnostics Corp. | 2005-02-07 |
| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | Phamatech, Inc. | 2004-12-29 |
| K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | Lin-Zhi International, Inc. | 2003-09-05 |
| K023048 | MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT | Beckman Coulter, Inc. | 2002-11-07 |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | OraSure Technologies, Inc. | 2002-04-17 |
| K013143 | BENZODIAZEPINES | Abbott Laboratories | 2002-03-13 |
| K012300 | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | ACON Laboratories, Inc. | 2001-09-17 |
| K012131 | LIVESURE BENZODIAZEPINES SCREEN TESTS | Pan Probe Biotech, Inc. | 2001-07-20 |
| K003879 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K003881 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K011306 | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 | Syva Co., Dade Behring, Inc. | 2001-05-16 |
| K002342 | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST | Branan Medical Corporation | 2000-11-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850013035417 | Identify®Diagnostics Drug Test Dips | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035424 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035530 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035547 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035554 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035561 | Identify Health | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035677 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035684 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035691 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035707 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10850013035400 | Identify®Diagnostics Drug Test Dip | MEDICAL DISTRIBUTION GROUP INC | 2026-05-28 |
| 10612479255293 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10612479255323 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10612479258430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| M09107RD7065220 | QuickProfile™ Drugs of Abuse Panel 6 Test | LUMIQUICK DIAGNOSTICS, INC. | 2017-11-15 |
| 10694644100157 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100140 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100133 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100126 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100119 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100102 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100096 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100089 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100072 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100065 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100058 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100041 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100034 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100027 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644100010 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |