A1c-Cellular 211130

GUDID 00844509000945

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.

STRECK, INC.

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 00844509000945
• NIH Device Record Key: e715292e-7337-4e7e-bdda-9672fcf8c878
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A1c-Cellular
• Version Model Number: 211130
• Catalog Number: 211130
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509000945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040025

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2016-09-19

On-Brand Devices [A1c-Cellular]

• 00844509000945: A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains on
• 00844509000938: A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3