PREMIER Coccidioides 603096

GUDID 00840733101236

The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).

MERIDIAN BIOSCIENCE, INC.

Coccidioides immitis total antibody IVD, kit, precipitation/immunodiffusion

• Primary Device ID: 00840733101236
• NIH Device Record Key: 0a8f7890-c949-4855-80eb-7e4dd6835547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIER Coccidioides
• Version Model Number: 603096
• Catalog Number: 603096
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, 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: 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: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915493

FDA Product Code

• MIY: Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

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: 2016-09-23

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