FDA.reportPublic FDA data

SIGNAL

Primary DI
06937579912127
Brand
SIGNAL
Company
NANTONG EGENS BIOLOGY TECHNIC CO., LTD.
Model
THC-U24
Published
2018-07-17
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical 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
06937579912127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937579912127069375799121276937579912127

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
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 CompanyLAF2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLAF2026-06-02
10841824104737EZ CLICKW.H.P.M. INC.LAF2024-07-25
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LAF2024-02-09
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LAF2023-11-30
B298305250DrugCheck Express Diagnostic Int'l, Inc.LAF2023-11-30
10833143000067iCup™Instant Technologies, Inc.LAF2023-09-12
10817763022609First SignW.H.P.M. INC.LAF2022-11-17
20869419000209Express ResultsTM Quest DiagnosticsLAF2022-03-28
10841824104843NAW.H.P.M. INC.LAF2021-10-12
10841824104812ECO II Cup ®W.H.P.M. INC.LAF2021-09-10
10817815020683CRL Stat Dip CardW.H.P.M. INC.LAF2021-08-25
10841824104805NAW.H.P.M. INC.LAF2021-08-25
10841824104782ECO II Cup ®W.H.P.M. INC.LAF2021-07-08
B2983057210DrugCheckExpress Diagnostic Int'l, Inc.LAF2021-06-18
10817405021304iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021311iScreen™Instant Technologies, Inc.LAF2020-08-21
10817405021328iScreen™Instant Technologies, Inc.LAF2020-08-21
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10858886006480NOBLE NOBLE MEDICAL INCLAF2020-04-21
B2983044510DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23
B2983050110DrugCheckExpress Diagnostic Int'l, Inc.LAF2019-04-23