Prime Screen DWDOA-754-5BX-A
GUDID 10816862023678
5-Panel Card; 5 per box; AMP,BZO,COC,OPI,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, 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 | 10816862023678 |
| NIH Device Record Key | 15efdb2a-0ce4-4d25-a358-04f16a765183 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prime Screen |
| Version Model Number | DWDOA-754-5BX-A |
| Catalog Number | DWDOA-754-5BX-A |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 5 |
| 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 | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862023671 [Primary] |
| GS1 | 00816862023688 [Unit of Use] |
| GS1 | 10816862023678 [Package] Contains: 00816862023671 Package: [90 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202567
FDA Product Code
| NFT | Test, Amphetamine, Over The Counter |
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 | 2022-02-21 |
| Device Publish Date | 2022-02-11 |
On-Brand Devices [Prime Screen]
| 10816862023678 | 5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC |
| 10816862024026 | Prime Screen® Multi-Panel Urine Test (10 Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC |
| 10816862024002 | Prime Screen® Multi-Panel Urine Test (12-Panel Card: AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, |
| 10816862023982 | Prime Screen® Multi-Panel Urine Test (5-Panel Card: AMP, COC, mAMP, OPI, THC), 5T/Bo |
| 10816862023944 | 14-Panel T-Cup 5 per Box; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC |
| 10816862023906 | Prime Screen® 5-Panel T-Square with indicator; 5 per Box; AMP, COC, MET, OPI, THC |
| 10816862023883 | 7-Panel T-Square with Indicator; 25 per box; AMP,COC,MET,OPI,OXY,PCP,THC |
| 10816862023869 | 7-Panel T-Square with Indicator; 5 per box; AMP,COC,MET,OPI,OXY,PCP,THC |
| 10816862023845 | 10-Panel T-Square with indicator; 25 per box; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC |
| 10816862023746 | 12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC |
| 10816862023562 | 12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC |
| 10816862024187 | Prime Screen® 6-Panel T-Square with indicator: AMP, COC, MET, OPI, PCP, THC |
| 10816862024163 | Prime Screen® Multi-Drug Urine Test Cup, 14-Panel U-Cup, 5 per Box; AMP,BAR,BUP,BZO,COC,MET,MDM |
| 10816862024149 | Prime Screen® Multi-Drug Urine Test Cup, 12-Panel U-Cup, 5 per Box; AMP,BAR,BUP,BZO,COC,MET,MDM |
| 10816862024064 | Prime Screen® Multi-Drug Urine Test Cup( 12-Panel T-Cup: BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY, |
| 10816862023760 | 1-Panel Card; 25 per box; One Step THC Urine Test |
Trademark Results [Prime Screen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIME SCREEN 90820567 not registered Live/Pending |
Wondfo USA Co., Ltd. 2021-07-09 |
 PRIME SCREEN 87365782 5306042 Live/Registered |
Wondfo USA Co., Ltd. 2017-03-09 |
 PRIME SCREEN 74118744 not registered Dead/Abandoned |
K PRIME PARTNERS L.P. 1990-11-28 |
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