Bsure
GUDID 00816862025859
12-Panel Bsure Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
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, 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 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 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 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 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 | 00816862025859 |
| NIH Device Record Key | 3de2a789-008d-4f6d-ae36-31bc46868243 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bsure |
| Version Model Number | CDOA-6125 |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
| XX@XX.XX |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862025859 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133968
FDA Product Code
| LDJ | Enzyme Immunoassay, Cannabinoids |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-02 |
| Device Publish Date | 2018-10-02 |
Devices Manufactured by WONDFO USA CO., LTD.
| 10816862024101 - Wondfo | 2023-08-21 Nucleic Acid Extraction Kit: 96 Tests/Kit (96 Samples per Plate), 1 Sample Plate,3 Prefilled Reagent Plates,1 sealed vial with P |
| 10816862024125 - T-Cup | 2023-08-17 10-Panel T-Cup; AMP,BAR,BZO,COC,MDMA,MTD,OPI,OXY,PCP,THC |
| 10816862022756 - Wondfo | 2023-08-11 PREGNANCY MIDSTREAM TEST |
| 10816862023036 - T-Dip | 2023-08-11 3-Panel Card;COC300,OPI2000,THC50 |
| 10816862023722 - Preview | 2023-08-11 10-Strip; Strep A Throat Swab Test |
| 10816862023760 - Prime Screen | 2023-08-11 1-Panel Card; 25 per box; One Step THC Urine Test |
| 10816862023784 - Preview | 2023-08-11 25-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived |
| 10816862023807 - Wondfo | 2023-08-11 1-Cassette; hCG Pregnancy Test 25 mIU/mL CLIA Waived |
Trademark Results [Bsure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BSURE 86802562 4982883 Live/Registered |
Weno Exchange LLC 2015-10-28 |
 BSURE 85185375 not registered Dead/Abandoned |
SUN PHARMACEUTICALS INDUSTRIES LTD 2010-11-26 |
 BSURE 79001102 3076828 Dead/Cancelled |
GN Otometrics A/S 2004-01-30 |
 BSURE 77256248 not registered Dead/Abandoned |
Bsure.com, Inc. 2007-08-15 |
 BSURE 75669933 not registered Dead/Abandoned |
Matthews, Charles T. 1999-03-29 |
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