Prime Screen
GUDID 10816862023746
12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 10816862023746 |
| NIH Device Record Key | 05bddd07-3c8b-45ab-aba1-886e589fb780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prime Screen |
| Version Model Number | DTDOA-6125-2BX-A |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 2 |
| 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 | false |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862023749 [Primary] |
| GS1 | 00816862023756 [Unit of Use] |
| GS1 | 10816862023746 [Package] Contains: 00816862023749 Package: [48 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182701
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 | 2023-08-10 |
| Device Publish Date | 2023-08-02 |
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 |
| 10816862024552 | Prime Screen 14-Panel T-Cup: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC,25 per Bo |
| 10816862024514 | Prime Screen® Multi-Drug Urine Test Cup( 12-Panel C-Cup: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD, |
| 10816862024453 | Prime Screen® Multi-Drug Urine Test Cup( 12-Panel C-Cup: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD, |
| 10816862024439 | 12-Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC,5 per box |
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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