TECO DIAGNOSTICS URS-10-100T
GUDID 10673486000665
URS-10 100 Finished Kit for TC-Thunderbolt
TECO DIAGNOSTICS
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical| Primary Device ID | 10673486000665 |
| NIH Device Record Key | 5cd3c2b0-3099-40c0-a589-d6ac76bbfdb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECO DIAGNOSTICS |
| Version Model Number | URS-10-100 TC-THUNDERBOLT |
| Catalog Number | URS-10-100T |
| Company DUNS | 185067774 |
| Company Name | TECO DIAGNOSTICS |
| 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 | true |
| 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 | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486000665 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141289
FDA Product Code
| JRE | Refractometer For Clinical Use |
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 | 2019-05-14 |
| Device Publish Date | 2019-05-06 |
On-Brand Devices [TECO DIAGNOSTICS]
| 10673486000665 | URS-10 100 Finished Kit for TC-Thunderbolt |
| 10673486000658 | URS-10-100 Finished Kit / Gray Bottle |
| 10673486000146 | URS-1B-100 GENERIC |
| 10673486000139 | URS-1B-100 BOTTLE ONLY |
| 10673486000122 | URS-1B-100 FINISHED KIT |
| 10673486000085 | URS-1B-50-01 FINISHED KIT |
| 10673486000672 | URS-11 100 Strips Generic Finished Kit |
| 10673486000412 | URS 2L POUCH (UTI POUCH) |
| 10673486000399 | URS-9-100 BOTTLE ONLY |
| 10673486000382 | URS-9-100 FINISHED KIT |
| 10673486000092 | URS-1P 100 Teco Finished Kit |
| 10673486000696 | RPR, 1x500 Tests |
| 10673486000689 | RPR, 1x100 Tests |
| 10673486000542 | URS-1G-100 GENERIC LABELED BOTTLE |
| 10673486000177 | URS-1G-100 GENERIC FINISHED KIT |
| 10673486000160 | URS-1G-100 BOTTLE |
| 10673486000153 | URS-1G-100 FINISHED KIT |
| 10673486000641 | TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL |
| 10673486000634 | URS-4B-100-108 TECO DIAGNOSTICS FINISHED KIT |
| 10673486000627 | URS-4B-100 TECO DIAGNOSTICS FINISHED KIT |
| 10673486000610 | URS-6-100 TECO FINISHED KIT |
| 10673486000603 | URS-3-50 FINISHED KIT |
| 10673486000580 | URS-3-50-01 FINISHED KIT |
| 10673486000573 | URS-2M-25 GENERIC FINISHED KIT |
| 10673486000566 | URS-5K-50 FINISHED KIT |
| 10673486000559 | URS-3-100 GENERIC LABELED BOTTLE |
| 10673486000535 | URS-6L-100 FINISHED KIT |
| 10673486000450 | URS-OBGYN-100 FINISHED KIT |
| 10673486000443 | URS-11-50 TECO FINISHED KIT |
| 10673486000429 | URS-11-100 FINISHED KIT |
| 10673486000405 | URS-9-100 GENERIC FINISHED KIT |
| 10673486000375 | URS-5K-100 GENERIC FINISHED KIT |
| 10673486000368 | URS-5K-100 BOTTLE |
| 10673486000351 | URS-5K-100 FINISHED KIT |
| 10673486000344 | URS-4S-100 GENERIC FINISHED KIT |
| 10673486000337 | URS-4S-100 BOTTLE |
| 10673486000320 | URS-4S-100 FINISHED KIT |
| 10673486000313 | URS-3-100 GENERIC FINISHED KIT |
| 10673486000306 | URS-3-100 BOTTLE |
| 10673486000290 | URS-3-100 FINISHED KIT |
| 10673486000283 | URS-2P-100 GENERIC |
| 10673486000276 | URS-2P-100 BOTTLE |
| 10673486000269 | URS-2P-100 FINISHED KIT |
| 10673486000252 | URS-2M-25 BOTTLE |
| 10673486000245 | URS-2M-25 FINISHED KIT |
| 10673486000238 | URS-2K-100 GENERIC FINISHED KIT |
| 10673486000221 | URS-2K-100 BOTTLE ONLY |
| 10673486000214 | URS-2K-100 FINISHED KIT |
| 10673486000078 | URS-10-100 LABELED BOTTLE |
| 10673486000061 | URS-10-100 USA KIT |
Trademark Results [TECO DIAGNOSTICS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TECO DIAGNOSTICS 85436511 4153486 Live/Registered |
Teco Diagnostics 2011-09-30 |
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