HbA1c 12-H7546-40

GUDID 00811727013569

For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 00811727013569
• NIH Device Record Key: 5927e3ee-27a0-4b4d-88d2-255daa86395a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c
• Version Model Number: 12-H7546-40
• Catalog Number: 12-H7546-40
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, 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: 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: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727013569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031539

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

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: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [HbA1c]

• 00811727013569: For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination
• 00811727013545: For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination