TopCare
GUDID 00023513000039
OTC Single Use urinary test strip
REESE PHARMACEUTICAL COMPANY
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid| Primary Device ID | 00023513000039 |
| NIH Device Record Key | 4bdb2de5-a863-4688-9002-c0c4dcb77a2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TopCare |
| Version Model Number | UTES |
| Company DUNS | 004172052 |
| Company Name | REESE PHARMACEUTICAL COMPANY |
| Device Count | 3 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00023513000039 [Unit of Use] |
| GS1 | 00036800468450 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063295
FDA Product Code
| LJX | Test, Urine Leukocyte |
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 | 2020-08-24 |
| Device Publish Date | 2020-08-14 |
Devices Manufactured by REESE PHARMACEUTICAL COMPANY
| 10023513132157 - Reese's ColoTest | 2024-05-06 |
| 10023513132140 - Reese's ColoTest | 2024-01-31 |
| 00023513487441 - DG Health | 2021-12-22 OTC Single Use urinary test strip |
| 00023513000039 - TopCare | 2020-08-24OTC Single Use urinary test strip |
| 00023513000039 - TopCare | 2020-08-24 OTC Single Use urinary test strip |
Trademark Results [TopCare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOPCARE 98464730 not registered Live/Pending |
Onyeka Tony Osakwe 2024-03-23 |
 TOPCARE 90780839 not registered Live/Pending |
Topco Holdings, Inc. (Cooperative) 2021-06-17 |
 TOPCARE 90105070 not registered Live/Pending |
TopCare Insurance LLC 2020-08-10 |
 TOPCARE 90013975 not registered Live/Pending |
Topco Holdings, Inc. (Cooperative) 2020-06-22 |
 TOPCARE 87799114 5915552 Live/Registered |
Hillcour, Inc. 2018-02-15 |
 TOPCARE 86827212 4997640 Live/Registered |
TOP CARE LAWN SERVICE, INC. 2015-11-20 |
 TOPCARE 85757897 not registered Dead/Abandoned |
TOP-VOX Corporation 2012-10-18 |
 TOPCARE 78524321 3103270 Dead/Cancelled |
TELEDYNE CONTINENTAL MOTORS, INC. 2004-11-30 |
 TOPCARE 78524316 3028770 Dead/Cancelled |
TELEDYNE CONTINENTAL MOTORS, INC. 2004-11-30 |
 TOPCARE 76086414 2473557 Dead/Cancelled |
TELEDYNE CONTINENTAL MOTORS, INC. 2000-07-11 |
 TOPCARE 74536174 not registered Dead/Abandoned |
CIGNA Corporation 1994-06-10 |
 TOPCARE 73668913 1474704 Dead/Cancelled |
STERLING DRUG INC. 1987-06-29 |
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