FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MERIFLUOR EBV-NA
DI: 00840733101953
·
Model: EN100
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MERIFLUOR EBV-NA
- Primary DI
- 00840733101953
- Version / Model
- EN100
- Catalog Number
- EN100
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-26
- Public Version
- 2
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- bffbb3de-4d96-43fb-b0f0-90218e2c1375
- Distribution End Date
- 2023-06-30
Device Description
The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | Microbiology | 866.3235 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64978 | Epstein-Barr virus (EBV) antigen IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733101953 | GS1 |
Customer Contacts
- Phone
- 1-800-343-3858
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K880043 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius