Identity
- Trade Name
- CD38-APC (Clone REA671) FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Clone REA671 recognizes the human CD38 antigen, a single-chain type II transmembrane glycoprotein with enzymatic activity. It is present on the majority of hematopoietic cells, prevalent during early differentiation and activation processes. Terminally differentiated B cells (plasma cells) express CD38 brightly. Furthermore, CD38 is constitutively expressed in several tissues, for example, brain, muscle, and kidney. CD38, a disease marker for human leukemias and myelomas, plays a role in the pathogenesis and outcome of human immunodeficiency virus infection and chronic lymphocytic leukemia, and controls insulin release and also the development of diabetes. Furthermore, it catalyzes the synthesis and hydrolysis of cyclic ADP-ribose (cADPR) from NAD+ to ADP-ribose which is essential for the regulation of intracellular Ca2+. Additional information: Clone REA671 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-068 FDA UDI
- Description
- Clone REA671 recognizes the human CD38 antigen, a single-chain type II transmembrane glycoprotein with enzymatic activity. It is present on the majority of hematopoietic cells, prevalent during early differentiation and activation processes. Terminally differentiated B cells (plasma cells) express CD38 brightly. Furthermore, CD38 is constitutively expressed in several tissues, for example, brain, muscle, and kidney. CD38, a disease marker for human leukemias and myelomas, plays a role in the pathogenesis and outcome of human immunodeficiency virus infection and chronic lymphocytic leukemia, and controls insulin release and also the development of diabetes. Furthermore, it catalyzes the synthesis and hydrolysis of cyclic ADP-ribose (cADPR) from NAD+ to ADP-ribose which is essential for the regulation of intracellular Ca2+. Additional information: Clone REA671 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133916 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
CD38-APC (Clone REA671) by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI a5ef5f05-7991-44b1-a79f-f0c89502462a 35 fields · synced Jun 8, 2026