Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) B551-132

GUDID 10673486001273

Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) is used for the direct colorimetric determination of Urea Nitrogen (BUN) in human serum or plasma.

TECO DIAGNOSTICS

Urea IVD, reagent

• Primary Device ID: 10673486001273
• NIH Device Record Key: a993b4d7-f455-416e-a3b6-89d45755a302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)
• Version Model Number: B551-132
• Catalog Number: B551-132
• 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: false
• 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

Customer Support Contacts

• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864742

FDA Product Code

• CDL: Berthelot Indophenol, Urea Nitrogen

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: 2023-07-31
• Device Publish Date: 2023-07-21

On-Brand Devices [Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)]

• 10673486001273: Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) is used for the direct co
• 10673486001266: Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) is used for the direct co