FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Anti-Glutamate receptor (type NMDA) IFA
DI: 04049016092568
·
Model: FA 112d-2005-51
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-Glutamate receptor (type NMDA) IFA
- Primary DI
- 04049016092568
- Version / Model
- FA 112d-2005-51
- Company Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Labeler DUNS
- 322209263
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 4
- Public Version Date
- 2023-07-11
- Public Version Status
- Update
- Public Device Record Key
- c557b747-08c3-4cd3-8417-e8cee95a1c4f
- Distribution End Date
- 2023-06-28
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62318 | N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to N-methyl-D-aspartate (NMDA) receptor (a glutamate receptor) in a clinical specimen, using a fluorescent immunoassay method. It is used to aid in the diagnosis of the autoimmune condition NMDA encephalitis, which causes neurologic and psychiatric symptoms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016092568 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100017 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius