FDA UDI
In Commercial Distribution
🇺🇸 United States
CD185-APC
DI: 04049934134555
·
Model: 170-081-004
·
Miltenyi Biotec B.V. & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CD185-APC
- Primary DI
- 04049934134555
- Version / Model
- 170-081-004
- Company Name
- Miltenyi Biotec B.V. & Co. KG
- Labeler DUNS
- 342920388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-26
- Public Version
- 1
- Public Version Date
- 2021-04-05
- Public Version Status
- New
- Public Device Record Key
- 5b61dbbc-094a-4817-ba69-f5962289701e
Device Description
REA103 recognizes human CD185, which is a 42 kDa G-protein-coupled chemokine receptor and is also known as CXCR5, monocyte-derived receptor 15 (MDR15), or Burkitt lymphoma receptor-1 (BLR1). BLR-1 was originally identified on cells of Burkitt lymphoma and B cells. B cell attracting chemokine 1 (BCA-1), also known as B-lymphocyte chemoattractant (BLC) or CXCL13, is the ligand of CD185. It is further expressed on central memory CD4 T cells, T follicular helper cells, and on a migratory population of skin-derived dendritic cells. Additional information: Clone REA103 displays negligible binding to Fc receptors.
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64705 | Assay development analyte-specific reagent IVD | An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049934134555 | GS1 |
Customer Contacts
- Phone
- 800-367-6227
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 2 - 8 °C Protected from light.