FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioPlex 2200
DI: 00847865002448
·
Model: SW4_V2
·
BIO-RAD LABORATORIES, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioPlex 2200
- Primary DI
- 00847865002448
- Version / Model
- SW4_V2
- Catalog Number
- 6651170C
- Company Name
- BIO-RAD LABORATORIES, INC.
- Labeler DUNS
- 884513334
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 3
- Public Version Date
- 2019-11-07
- Public Version Status
- Update
- Public Device Record Key
- cb2a4918-285e-4fab-81d2-8ddaabdf033f
- Distribution End Date
- 2019-09-13
Device Description
ANA Screen with MDSS Assay Protocol File CD, SW4_v2
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 |
|---|---|---|---|---|
| LKO | ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL | Immunology | 866.5100 | 2 |
| MQA | ANTI-RIBOSOMAL P ANTIBODIES | Immunology | 866.5100 | 2 |
| LRM | ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL | Immunology | 866.5100 | 2 |
| LJM | ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS | Immunology | 866.5100 | 2 |
| LKJ | ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL | Immunology | 866.5100 | 2 |
| LLL | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54810 | Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847865002448 | GS1 |
Customer Contacts
- Phone
- +1(800)224-6723
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Each |