LZI Oxycodone III Enzyme Immunoassay
Lin-Zhi International, Inc.
LIN-ZHI INTERNATIONAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003610499 | 3003610499 | LIN-ZHI INTERNATIONAL, INC. | 1 | N | 2026-01-01 | 2945 Oakmead Village Ct Santa Clara CA US 95051 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 60178 | 1213241806 | K251634 | LZI Fentanyl III Enzyme Immunoassay | DJG | 2025-06-18 |
| 60178 | 2026766532 | K202007 | LZI Oxycodone III Enzyme Immunoassay | DJG | 2020-09-17 |
| 60178 | 1978527340 | K201938 | LZI Fentanyl II Enzyme Immunoassay | DJG | 2020-08-07 |
| 60178 | 1640156579 | K201223 | LZI Tramadol Enzyme Immunoassay | DJG | 2020-06-04 |
| 60178 | 1597465827 | K192433 | LZI Methadone II Enzyme Immunoassay | DJR | 2019-10-04 |
| 60178 | 2028726377 | K192299 | LZI Cotinine II Enzyme Immunoassay | MKU | 2019-11-21 |
| 60178 | 1380963004 | K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | 2018-12-03 |
| 60178 | 1708853441 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | DJR | 2017-06-26 |
| 60178 | 1249199248 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | LDJ | 2015-05-28 |
| 60178 | 1933050283 | K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 | DJG | 2015-02-13 |
| 60178 | 1832672842 | K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | DJG | 2014-06-13 |
| 60178 | 1895983734 | K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | DKB | 2014-02-21 |
| 60178 | 1958031831 | K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | DKZ | 2014-02-04 |
| 60178 | 1916235763 | K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | LAF | 2014-03-21 |
| 60178 | 1623081547 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | 2012-06-01 |
| 60178 | 1237513505 | K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | DJG | 2012-05-08 |
| 60178 | 1857994119 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | LAF | 2012-01-23 |
| 60178 | 1351587462 | K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | DIO | 2011-11-22 |
| 60178 | 1280191268 | K110298 | OPIATE ENZYME IMMUNOASSAY | DJG | 2011-07-15 |
| 60178 | 1981371203 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | 2011-06-23 |
| 60178 | 1004435219 | K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS | DKZ | 2010-12-28 |
| 60178 | 1784048662 | K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | DJG | 2010-07-06 |
| 60178 | 2015233472 | K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | DJG | 2009-07-30 |
| 60178 | 1470444670 | K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS | DJG | 2008-12-22 |
| 60178 | 1915435650 | K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) | DKZ | 2003-12-19 |
| 60178 | 1819434768 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | 2003-11-03 |
| 60178 | 1868565616 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | DIC | 2003-10-03 |
| 60178 | 1506306288 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | 2003-09-05 |
| 60178 | 1501068390 | K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) | DJR | 2003-10-10 |
| 60178 | 1398254821 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | JXN | 2003-01-21 |
| 60178 | 1309353619 | K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | 2002-12-12 |
| 60178 | 1826141145 | K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | 2002-12-16 |
| 60178 | 1927026985 | K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | 2002-04-03 |
| 60178 | 1141864777 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | DIO | 2002-05-10 |
| 60178 | 1102205841 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | DKZ | 2002-06-04 |
| 60178 | 1055758423 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | LCM | 2002-05-10 |
| 60178 | 1839332562 | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | QBK | 2018-04-20 |
| 60178 | 1046837632 | ||||
| 60178 | 1200326773 | ||||
| 60178 | 1231840834 | ||||
| 60178 | 2014613754 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DJG | 13 | 2025-06-18 |
| DJR | 4 | 2019-10-04 |
| DKZ | 4 | 2014-02-04 |
| LDJ | 2 | 2015-05-28 |
| LAF | 2 | 2014-03-21 |
| DIO | 2 | 2011-11-22 |
| DLJ | 2 | 2002-12-16 |
| MKU | 1 | 2019-11-21 |
| QBK | 1 | 2018-04-20 |
| DKB | 1 | 2014-02-21 |
| DIS | 1 | 2003-11-03 |
| DIC | 1 | 2003-10-03 |
| JXM | 1 | 2003-09-05 |
| JXN | 1 | 2003-01-21 |
| LCM | 1 | 2002-05-10 |
PMN#
LZI Fentanyl II Enzyme Immunoassay
Lin-Zhi International, Inc.
LZI Tramadol Enzyme Immunoassay
Lin-Zhi International, Inc.
LZI Cotinine II Enzyme Immunoassay
Lin-Zhi International, Inc.
LZI Fentanyl Enzyme Immunoassay
Lin-Zhi International, Inc.
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 And 300) Calibrators
Lin-Zhi International, Inc.
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators And LZI Oral Fluid Cannabinoids Controls
Lin-Zhi International, Inc.
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
Lin-Zhi International, Inc.
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
Lin-Zhi International, Inc.
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
Lin-Zhi International, Inc.
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
Lin-Zhi International, Inc.
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
Lin-Zhi International, Inc.
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
Lin-Zhi International, Inc.
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
Lin-Zhi International, Inc.
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
Lin-Zhi International, Inc.
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
Lin-Zhi International, Inc.
OPIATE ENZYME IMMUNOASSAY
Lin-Zhi International, Inc.
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
Lin-Zhi International, Inc.
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
Lin-Zhi International, Inc.
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Lin-Zhi International, Inc.
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
Lin-Zhi International, Inc.
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
Lin-Zhi International, Inc.
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
Lin-Zhi International, Inc.
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
Lin-Zhi International, Inc.
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
Lin-Zhi International, Inc.
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
Lin-Zhi International, Inc.
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
Lin-Zhi International, Inc.
BENZODIAZEPINE ENZYME IMMUNOASSAY
Lin-Zhi International, Inc.
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
Lin-Zhi International, Inc.
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
METHADONE ENZYME IMMUNOASSAY
Lin-Zhi International, Inc.
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
Lin-Zhi International, Inc.
GUDID#
LZI Fentanyl III Enzyme Immunoassay - Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL
2026-07-17
LZI Fentanyl III Enzyme Immunoassay - Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL Enzyme Conjugate Reagent (R2): 375 mL
2026-07-17
LZI Fentanyl Cutoff Calibrator - 5 mL/bottle Concentration: 1 ng/mL of Fentanyl
2026-07-17
LZI Fentanyl Level 1 Control - 5 mL/bottle Concentration: 0.5 ng/mL of Fentanyl
2026-07-17
LZI Fentanyl Level 2 Control - 5 mL/bottle Concentration: 1.5 ng/mL of Fentanyl
2026-07-17
Fentanyl II Enzyme Immunoassay - 850 tests. c pack green, PChAntibody/Substrate Reagent (R1): 1 x 63.3 mLEnzyme Conjugate Reagent (R2): 1 x 26.9 mL
2025-11-17
LZI Fentanyl III Enzyme Immunoassay - Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mLEnzyme Conjugate Reagent (R2): 375 mL
2025-10-13
LZI Fentanyl Qualitative Calibrator - FEN Cutoff Calibrator 1 ng/mL (1 x 5 mL)
2025-10-13
LZI Fentanyl Level 1 Control - FEN Level 1 Control 0.5 ng/mL (1 x 5 mL)
2025-10-13
LZI Fentanyl Level 2 Control - FEN Level 2 Control 1.5 ng/mL (1 x 5 mL)
2025-10-13
LZI Fentanyl III Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 100 mLEnzyme Conjugate Reagent (R2): 37.5 mL
2025-10-13
Fentanyl Control Set - FEN Negative Control 3.75 ng/mL (2 x 15 mL),FEN Positive Control 6.25 ng/mL (2 x 15 mL).
2025-06-06
Amphetamines Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
2016-07-05
Amphetamines Enzyme Immunoassay - Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.
2016-07-05
Amphetamines 500 Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
2016-07-05
Amphetamines 500 Enzyme Immunoassay - Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.
2016-07-05
Ecstasy Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
2016-07-05
Ecstasy Enzyme Immunoassay - Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.
2016-07-05
Ecstasy DAU Calibrator, Low Calibrator - 5mL/bottle.Concentration: 100 ng/mL of MDMA.
2016-07-05
Ecstasy DAU Calibrator, Cutoff Calibrator - 5mL/bottle.Concentration: 500 ng/mL of MDMA.
2016-07-05
Ecstasy DAU Calibrator, Intermediate Calibrator - 5mL/bottle.Concentration: 750 ng/mL of MDMA.
2016-07-05
Ecstasy DAU Calibrator, High Calibrator - 5mL/bottle.Concentration: 1000 ng/mL of MDMA.
2016-07-05
Ecstasy DAU Control, Level 1 Control - 5mL/bottle.Concentration: 375 ng/mL of MDMA.
2016-07-05
Ecstasy DAU Control, Level 2 Control - 5mL/bottle.Concentration: 625 ng/mL of MDMA.
2016-07-05
Cannabinoids DAU Calibrator, Negative Calibrator - 5mL/bottle.Concentration: 0 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Control, Control - 5mL/bottle.Concentration: 18.75 ng/mL of 11-nor-Δ9-THC-9-COOH
2016-07-05
Cannabinoids DAU Calibrator/Control, Calibrator/Control - 5mL/bottle.Concentration: 37.5 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Control, Control - 5mL/bottle.Concentration: 62.5 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Control, Control - 5mL/bottle.Concentration: 125 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoid Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
2016-07-05
Cannabinoid Enzyme Immunoassay - Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 12.5 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 25 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Control, Control - 5mL/bottle.Concentration: 31.25 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 50 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator/Control, Calibrator/Control - 5mL/bottle.Concentration: 75 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 100 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 150 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Cannabinoids DAU Calibrator, Calibrator - 5mL/bottle.Concentration: 200 ng/mL of 11-nor-Δ9-THC-9-COOH.
2016-07-05
Oral Fluid Cannabinoid Enzyme Immunoassay - Small Test Kit.Antibody/Substrate Reagent (R1): 75 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
2016-07-05