FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Rad
DI: 03610522051076
·
Model: 12008533
·
Bio-RAD Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Rad
- Primary DI
- 03610522051076
- Version / Model
- 12008533
- Catalog Number
- 12008533
- Company Name
- Bio-RAD Laboratories, Inc.
- Labeler DUNS
- 844766394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-28
- Public Version
- 3
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 3a182924-e488-4a17-b04a-b1a3ede7365b
Device Description
HSV Type 1 Specific IgG EIA Test Set
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 |
|---|---|---|---|---|
| MXJ | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 | Microbiology | 866.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49568 | Herpes simplex virus 1 (HSV1) 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 1 (HSV1) 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 | 03610522051076 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162276 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 Tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius