Identity
- Trade Name
- Anti-Glutamate receptor (type NMDA) IFA FDA UDI
- Generic Name
- N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- FA 112d-2010-51 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016092575 FDA UDI
- 510(k) Number
- K100017 FDA UDI
- FDA Product Code
- OSK FDA UDI
- GMDN Term
- N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Anti-Glutamate receptor (type NMDA) IFA by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 6baaedd3-a698-4ce8-ac67-eef5d676fca9 35 fields · synced Jun 1, 2026