Teco Diagnostics Hemoglobin Reagent Set H526-480

GUDID 10673486001914

Teco Diagnostics Hemoglobin Reagent Set is used for the quantitative determination of hemoglobin in human blood.

TECO DIAGNOSTICS

Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent

• Primary Device ID: 10673486001914
• NIH Device Record Key: 74188fcc-b70f-4d26-a261-24196f65bf92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Hemoglobin Reagent Set
• Version Model Number: H526-480
• Catalog Number: H526-480
• 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: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883683

FDA Product Code

• GJZ: Cyanomethemoglobin Reagent And Standard Solution

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: 2023-11-20
• Device Publish Date: 2023-11-10

On-Brand Devices [Teco Diagnostics Hemoglobin Reagent Set]

• 10673486001921: Teco Diagnostics Hemoglobin Reagent Set is used for the quantitative determination of hemoglobin
• 10673486001914: Teco Diagnostics Hemoglobin Reagent Set is used for the quantitative determination of hemoglobin