HbA1c

GUDID 03701700821304

VITALSCIENTIFIC

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 03701700821304
• NIH Device Record Key: c75f116b-277b-407e-8b4d-3fe80eeb179d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c
• Version Model Number: HBAC-0240
• Company DUNS: 267732378
• Company Name: VITALSCIENTIFIC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701700821304 [Primary]

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: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by VITALSCIENTIFIC

• 03701700800019 - ENVOY 500 ALBUMIN REAGENT KIT: 2025-04-08
• 03701700800026 - ENVOY 500 ALT REAGENT KIT: 2025-04-08
• 03701700800033 - ENVOY 500 AMYLASE REAGENT KIT: 2025-04-08
• 03701700800040 - ENVOY 500 AST REAGENT KIT: 2025-04-08
• 03701700800057 - ENVOY 500 URIC ACID REAG.KIT: 2025-04-08
• 03701700800064 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT: 2025-04-08
• 03701700800071 - ENVOY 500 TOTAL BILIRUBIN REAGENT KIT: 2025-04-08
• 03701700800088 - ENVOY 500 CALCIUM REAGENT KIT: 2025-04-08