FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Rad Platelia
DI: 05391516746540
·
Model: 72936
·
CLARK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Rad Platelia
- Primary DI
- 05391516746540
- Version / Model
- 72936
- Catalog Number
- 72936
- Company Name
- CLARK LABORATORIES, INC.
- Labeler DUNS
- 623214079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-07
- Public Version
- 1
- Public Version Date
- 2019-11-15
- Public Version Status
- New
- Public Device Record Key
- 2674f35f-17ae-4f5c-a8a5-b290d31b6e4f
Device Description
EBV-VCA IgM
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | Microbiology | 866.3235 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49662 | Epstein-Barr virus (EBV) immunoglobulin M (IgM) 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 M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) 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 | 05391516746540 | GS1 |
Customer Contacts
- Phone
- 1-800-325-3424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980596 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius