FDA UDI
In Commercial Distribution
🇺🇸 United States
BioPlex 2200
DI: 00847865010986
·
Model: SW4.1_V1
·
BIO-RAD LABORATORIES, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BioPlex 2200
- Primary DI
- 00847865010986
- Version / Model
- SW4.1_V1
- Catalog Number
- 6653270E
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 884513334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2021-07-29
- Public Version Status
- Update
- Public Device Record Key
- 387dce1a-37df-444c-86ec-a6741c0060c9
Device Description
BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | Clinical Chemistry | 862.1150 | 2 |
| NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | Immunology | 866.5775 | 2 |
| JJY | Multi-analyte controls, all kinds (assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54897 | Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide antibody (CCP) in a clinical specimen, using a multiplex method. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865010986 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Each |