Dimension Clinical Chemistry System A1C Kit DF105B

GUDID 00630414006659

A1C Reagent Kit

Siemens Healthcare Diagnostics Inc.

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

• Primary Device ID: 00630414006659
• NIH Device Record Key: 110a0dd9-f385-4995-9513-bfa508b1b3a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimension Clinical Chemistry System A1C Kit
• Version Model Number: 10720883
• Catalog Number: DF105B
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• 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: false
• 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: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.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
• 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	00630414006659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173909

FDA Product Code

• PDJ: Hemoglobin A1c test system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-09
• Device Publish Date: 2018-12-06

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