Autostat II ENA-6 Screen

GUDID 00816879020144

96 well ELISA for the detection of anti-ENA antibodies in human serum

HYCOR BIOMEDICAL LLC

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00816879020144
• NIH Device Record Key: 6ccf7f17-9437-4c8f-a731-284c318e77f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autostat II ENA-6 Screen
• Version Model Number: FGA14
• Company DUNS: 010558476
• Company Name: HYCOR BIOMEDICAL LLC
• 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: true
• Lot Batch: true
• Serial Number: true
• 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: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.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
• 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	00816879020144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983921

FDA Product Code

• LLL: Extractable Antinuclear Antibody, Antigen And Control

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: 2016-09-26

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