Identity
- Trade Name
- CD197-PE FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA108 recognizes human CD197 which is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV) and is also known as CCR7. For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-). FDA UDI
- Model / Reference
- 170-081-034 FDA UDI
- Description
- REA108 recognizes human CD197 which is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV) and is also known as CCR7. For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134258 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assay development analyte-specific reagent IVD
Cd197-Pe by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assay development analyte-specific reagent IVD.
- PE/Dazzle™ 594 anti-human CD38 — BIOLEGEND, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- Beckmancoulter — Immunotech Corp. · Class I
- MetaSystems Probes — MetaSystems Probes GmbH · Class I
- Helicobacter Pylori (EP279) — BIO SB, INC. · Class I
- CytoCell — Cytocell, Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI b1c4134b-81a6-46b9-9385-4887a0709ef5 35 fields · synced Jun 8, 2026