FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Anti-HSV-2 (gG2) ELISA (IgG)
DI: 04049016096733
·
Model: EI 2532-9601-24 G
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti-HSV-2 (gG2) ELISA (IgG)
- Primary DI
- 04049016096733
- Version / Model
- EI 2532-9601-24 G
- 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
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2024-11-18
- Public Version Status
- Update
- Public Device Record Key
- 562cc5b2-159a-4abe-a35e-30adff2a9a36
- Distribution End Date
- 2024-11-16
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 |
|---|---|---|---|---|
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | Microbiology | 866.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49595 | Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016096733 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061239 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius