FDA.reportPublic FDA data

EGENS

Primary DI
06937579911373
Brand
EGENS
Company
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
Model
THC-U23
Published
2017-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152643000EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette MarijuanaNantong Egens Biotech Co., Ltd.2015-11-02LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937579911373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937579911373069375799113736937579911373

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654510689
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937579915357Good NeighborHCG-M022024-08-26
06937579915371Good NeighborHCG-M012024-08-26
06937579915395Good NeighborHCG-M012024-08-26
06937579915418Good NeighborLH-M012024-08-26
06937579915463Foster & ThriveHCG-M012024-08-26
06937579915340Good NeighborHCG-M022024-08-26
06937579915364Good NeighborHCG-M022024-08-26
06937579915388Good NeighborHCG-M012024-08-26
06937579915401Good NeighborHCG-M012024-08-26
06937579915425Good NeighborLH-M012024-08-26
06937579915456Foster & ThriveHCG-M022024-08-26
06937579915470Foster & ThriveHCG-M012024-08-26
06937579912370PARAIDHCG-M042023-08-11
06937579914596EGENSLH-S2023-08-11
06937579914602EGENSLH-C2023-08-11
06937579914619EGENSLH-M2023-08-11
06937579913735sunmarkHCG-M012022-11-14
06937579913858SmilecareHCG-S32022-11-14
06937579914107RITE AIDHCG-M022023-02-03
06937579914121RITE AIDHCG-M022023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncLDJ2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-13