Anti-Glutamate receptor (type NMDA) IFA

GUDID 04049016092551

EUROIMMUN Medizinische Labordiagnostika AG

N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 04049016092551
• NIH Device Record Key: d1174a6a-d115-49bf-9dae-e9918eafa4ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Glutamate receptor (type NMDA) IFA
• Version Model Number: FA 112d-1010-51
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016092551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100017

FDA Product Code

• OSK: Anti-Glutamate Receptor (Type Nmda) Ifa

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: 2016-10-10

On-Brand Devices [Anti-Glutamate receptor (type NMDA) IFA]

• 04049016092575: FA 112d-2010-51
• 04049016092568: FA 112d-2005-51
• 04049016092551: FA 112d-1010-51
• 04049016092544: FA 112d-1005-51
• 04049016092537: FA 112d-1003-51