FDA.reportPublic FDA data

LZI Oral Fluid Collectors

Primary DI
B076S0000B1
Brand
LZI Oral Fluid Collectors
Company
LIN-ZHI INTERNATIONAL, INC.
Model
S0000b
Catalog number
S0000b
Device description
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
DLJCalibrators, Drug Specific
LAFGas Chromatography, Methamphetamine
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
DLJCalibrators, Drug SpecificClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LASDrug Specific Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131652000
K131653000
K141205000
K141320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131652000LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSLin-Zhi International, Inc.2014-03-21LAF
K131653000LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSLin-Zhi International, Inc.2014-02-04DKZ
K141205000LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6Lin-Zhi International, Inc.2015-02-13DJG
K141320000LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids ControlsLin-Zhi International, Inc.2015-05-28LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B076S0000B1PrimaryHIBCC0
B076S0000B0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing specimen collection kit IVDA covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
840839190
Device count
50
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850624008643Fentanyl II Enzyme Immunoassay10427531190104275311902025-11-17
00850624008544LZI Fentanyl III Enzyme ImmunoassayC82916C829162025-10-13
00850624008650LZI Fentanyl Qualitative CalibratorD26784D267842025-10-13
00850624008667LZI Fentanyl Level 1 ControlD26785D267852025-10-13
00850624008674LZI Fentanyl Level 2 ControlD26786D267862025-10-13
00850624008681LZI Fentanyl III Enzyme ImmunoassayD29739D297392025-10-13
00850624008636Fentanyl Control Set10426667190104266671902025-06-06
B07600400Amphetamines Enzyme Immunoassay004000402016-07-05
B07600410Amphetamines Enzyme Immunoassay004100412016-07-05
B07601000Amphetamines 500 Enzyme Immunoassay010001002016-07-05
B07601010Amphetamines 500 Enzyme Immunoassay010101012016-07-05
B07601600Ecstasy Enzyme Immunoassay016001602016-07-05
B07601610Ecstasy Enzyme Immunoassay016101612016-07-05
B07601620Ecstasy DAU Calibrator, Low Calibrator016201622016-07-05
B07601630Ecstasy DAU Calibrator, Cutoff Calibrator016301632016-07-05
B07601640Ecstasy DAU Calibrator, Intermediate Calibrator016401642016-07-05
B07601650Ecstasy DAU Calibrator, High Calibrator016501652016-07-05
B07601670Ecstasy DAU Control, Level 1 Control016701672016-07-05
B07601680Ecstasy DAU Control, Level 2 Control016801682016-07-05
B0760002C0Cannabinoids DAU Calibrator, Negative Calibrator0002c0002c2016-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28