Healgen HCDOAF-5114A6
GUDID 20816490021692
11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
Healgen Scientific Limited Liability Company
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 20816490021692 |
| NIH Device Record Key | 348b944c-966f-4b9a-abed-8f6e3b11fac4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Healgen |
| Version Model Number | HCDOAF-5114A6 |
| Catalog Number | HCDOAF-5114A6 |
| Company DUNS | 031802328 |
| Company Name | Healgen Scientific Limited Liability Company |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com | |
| Phone | 7137338088 |
| bryan@healgen.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816490021698 [Primary] |
| GS1 | 10816490021695 [Package] Contains: 00816490021698 Package: Inner Pack [25 Units] In Commercial Distribution |
| GS1 | 20816490021692 [Package] Contains: 10816490021695 Package: Case [4 Units] In Commercial Distribution |
FDA Product Code
| LAF | Gas Chromatography, Methamphetamine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-05-09 |
On-Brand Devices [Healgen]
| 20816490022019 | 10 Panel DOA Test clear Round Cup With Clicker |
| 20816490022002 | 12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsCRE/SG/pH |
| 20816490021999 | 12 Panel DOA Test Dipcard |
| 20816490021982 | 6 Panel DOA Test Clear Round Cup ; |
| 20816490021975 | 12 Panel DOA Test Clear Round Cup ; |
| 20816490021968 | 12 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH |
| 20816490021951 | 5 Panel DOA Test Clear Round Cup ; |
| 20816490021944 | 5 Panel DOA Test Clear Round Cup ; |
| 20816490021937 | 5 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021913 | 3 Panel DOA Test Dipcard |
| 20816490021890 | 10 Panel DOA Test Dipcard |
| 20816490021883 | 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH |
| 20816490021876 | 6 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021869 | 7 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021852 | 17 Panel DOA Test clear Round Cup |
| 20816490021838 | 12 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH |
| 20816490021821 | 12 Panel DOA Test Clear Flat Cup |
| 20816490021814 | 7 Panel DOA Test clear Round Cup With Clicker |
| 20816490021784 | LH Ovulation Rapid Test Strip(Urine,25mIU/mL) |
| 20816490021777 | 7 Panel DOA Test Dipcard |
| 20816490021760 | 11 Panel DOA Test Dipcard |
| 20816490021753 | 12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test Strips CRE/SG/pH |
| 20816490021746 | 12 Panel DOA Test clear Round Cup With Clicker;+ Adulterant Test StripsOXI/SG/pH |
| 20816490021739 | 10 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021722 | 7 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021715 | 12 Panel DOA Test Dipcard |
| 20816490021708 | 7 Panel DOA Test Dipcard |
| 20816490021692 | 11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT |
| 20816490021685 | 6 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT |
| 20816490021678 | 10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH |
| 20816490021661 | 5 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021654 | 12 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021647 | 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH |
| 20816490021630 | 12 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021623 | 5 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021616 | 5 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021609 | Single Panel DOA Test Dipcard |
| 20816490021593 | 12 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021586 | 10 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021579 | 12 Panel DOA Test Clear Flat Cup + Adulterant Test Strips OXI/SG/CRE |
| 20816490021562 | 10 Panel DOA Test Dipcard |
| 20816490021555 | 12 Panel DOA Test Dipcard |
| 20816490021548 | 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH |
| 20816490021531 | 10 Panel DOA Test Dipcard |
| 20816490021524 | 10 Panel DOA Test Dipcard |
| 20816490021517 | 10 Panel DOA Test Dipcard |
| 20816490021500 | 9 Panel DOA Test Dipcard |
| 20816490021494 | 12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH |
| 20816490021487 | 12 Panel DOA Test clear Round Cup With Clicker; |
| 20816490021470 | 12 Panel DOA Test clear Round Cup With Clicker; |
Trademark Results [Healgen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEALGEN 98189738 not registered Live/Pending |
Healgen Scientific 2023-09-20 |
 HEALGEN 97690911 not registered Live/Pending |
Healgen Scientific Limited Liability Company 2022-11-23 |
 HEALGEN 88928128 not registered Live/Pending |
Healgen Scientific Limited Liability Company 2020-05-21 |
 HEALGEN 88722478 not registered Live/Pending |
Anji Shengyixing Trading Co., Ltd. 2019-12-11 |
 HEALGEN 85582915 4241735 Live/Registered |
HEALGEN SCIENTIFIC LIMITED LIABILITY COM 2012-03-28 |
 HEALGEN 85329912 4151565 Live/Registered |
Healgen Scientific Limited Liability Company 2011-05-25 |
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