TECO DIAGNOSTICS URS-1G-100
GUDID 10673486000153
URS-1G-100 FINISHED KIT
TECO DIAGNOSTICS
Urine glucose IVD, kit, colorimetric dipstick, rapid| Primary Device ID | 10673486000153 |
| NIH Device Record Key | e6bb7a04-5936-4e13-9526-2645bb363835 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECO DIAGNOSTICS |
| Version Model Number | URS-1G-100 |
| Catalog Number | URS-1G-100 |
| 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 | true |
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 | 10673486000153 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942648
FDA Product Code
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2016-10-04 |
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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