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| 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 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| 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 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
| XX@XX.XX | |
| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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| Phone | 1-800-985-3422 |
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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 |
| 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.
| 00816862027723 - HORMONElife™ | 2026-01-23 HORMONElife™ Early Result Pregnancy Test Strip Rx |
| 00816862028164 - SAFElife™ | 2026-01-23 13-Panel T-Cup Compact; AMP1000,BAR300,BUP10,BZO300,COC300,FTY1,MDMA500,MET1000,MOP300,MTD300,OXY100,PCP25,TCA1000 |
| 00816862028263 - HORMONElife™ | 2026-01-23 HORMONElife™ Pregnancy Test Strip; 25 mIU/mL OTC; 20 Tests per Bag |
| 00816862028010 - SAFElife™ | 2025-12-23 14-Panel T-Cup Compact; AMP500,BAR300,BUP10,BZO300,COC150,FTY1,MDMA500,MET500,MOP300,MTD300,OXY100,PCP25,TCA1000,THC50 |
| 00816862028072 - SAFElife™ | 2025-12-23 13-Panel T-Cup Compact; AMP500,BAR300,BUP10,BZO300,COC150,FTY1,MDMA500,MET500,MOP300,MTD300,OXY100,PCP25,THC50 with CR/pH/S.G. |
| 00816862028096 - HORMONElife™ | 2025-12-23 HORMONElife™ Ovulation Test Strip; 25 mIU/mL OTC; 50 Tests per Bag |
| 00816862028119 - HORMONElife™ | 2025-12-23 HORMONElife™ Pregnancy Test Cassette Rx; 25 mIU/mL CLIA Waived; 25 Tests per Kitbox |
| 00810174470857 - SAFElife™ | 2025-12-15 SAFElife 1-Panel Card 10 per Box; One Step THC Urine Test |
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 79408329 not registered Live/Pending |
BSURE AS 2024-06-10 |
 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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