FDA UDI
In Commercial Distribution
🇺🇸 United States
CD45RA-APC
DI: 04049934134562
·
Model: 170-081-003
·
Miltenyi Biotec B.V. & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CD45RA-APC
- Primary DI
- 04049934134562
- Version / Model
- 170-081-003
- 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
- 90fac894-b447-4e7d-897b-56cc08ab94a8
Device Description
T6D11 recognizes the human CD45RA antigen which is expressed on naive CD4+ and CD8+ T cells as well as on CD8+ effector T cells. CD45RA is also present on subsets of B and NK cells as well as on plasmacytoid dendritic cells. The CD45RA antibody recognizes the 220 kDa isoform of the leukocyte common antigen (LCA), a transmembrane tyrosine phosphatase.
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 | 04049934134562 | GS1 |
Customer Contacts
- Phone
- 800-367-6227
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 2 - 8 °C Protected from light.