FDA UDI
In Commercial Distribution
🇺🇸 United States
BioPlex 2200
DI: 03610520506424
·
Model: 12000879
·
BIO-RAD LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioPlex 2200
- Primary DI
- 03610520506424
- Version / Model
- 12000879
- Catalog Number
- 12000879
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 884513334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-30
- Public Version
- 3
- Public Version Date
- 2020-01-23
- Public Version Status
- Update
- Public Device Record Key
- d32e3418-e92a-4499-aa09-7aaaf8074455
Device Description
BioPlex 2200 Lyme Total Control 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
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50570 | Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03610520506424 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183446 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.5 | Milliliter | |
| Device Size Text, specify | 6 Vials |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius