ACON SARS-CoV-2 IgG/IgM Rapid Test 200979

GUDID 20682607200973

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)

ACON LABORATORIES, INC.

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 20682607200973
• NIH Device Record Key: 6244f1ab-86ac-4a61-ae08-470358c4c934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACON SARS-CoV-2 IgG/IgM Rapid Test
• Version Model Number: L031-11711
• Catalog Number: 200979
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, INC.
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607002269 [Unit of Use]
GS1	00682607200979 [Primary]
GS1	20682607200973 [Package]; Contains: 00682607200979; Package: Carton [45 Units]; In Commercial Distribution

FDA Product Code

• QKO: Reagent, coronavirus serological

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: 2021-02-16
• Device Publish Date: 2021-02-08

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