Accu-Sed® Test Kit, 4x8.5mL 2 Normal & 2 Abnormal

GUDID 03661540304071

Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.

ELITECHGROUP INC.

Erythrocyte sedimentation rate (ESR) IVD, control

• Primary Device ID: 03661540304071
• NIH Device Record Key: 8ddf838e-f159-405b-bfae-245d876f11bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Sed® Test Kit, 4x8.5mL 2 Normal & 2 Abnormal
• Version Model Number: DS-71006
• Company DUNS: 052423787
• Company Name: ELITECHGROUP INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com
• Phone: 1-800-453-2725
• Email: service_ebs@elitechgoup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540304071 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-01
• Device Publish Date: 2021-02-19

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• 03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton: 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
• 03661540300257 - Excyte® ESR Vacuum Tubes, Carton: 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy
• 03661540300264 - Excyte® ESR Vacuum Tube, Carton: 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy