TECO DIAGNOSTICS URS-1K-100B

GUDID 10673486000191

URS-1K-100 BOTTLE ONLY

TECO DIAGNOSTICS

Urine ketone IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 10673486000191
• NIH Device Record Key: 83dad081-72a9-45c0-98d5-ab73f66f7751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TECO DIAGNOSTICS
• Version Model Number: URS-1K-100 BOTTLE
• Catalog Number: URS-1K-100B
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486000191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003987

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2022-11-28
• 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