Identity
- Trade Name
- CD44-FITC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- DB105 recognizes the CD44 antigen. CD44 is a marker for many types of cancer stem cells (CSC), including breast CSCs that possess higher tumorigenicity and metastatic potential, colorectal, pancreatic, and prostate CSCs. In addition, expression was observed in several cancers as well as on carcinoma cell lines. Here, CD44 plays a role in cancer cell migration and matrix adhesion in response to a cellular microenvironment, thus enhancing cellular aggregation and tumor cell growth. CD44 is also expressed on mesodermal cells, such as hematopoietic, fibroblastic, and glial cells. FDA UDI
- Model / Reference
- 170-081-032 FDA UDI
- Description
- DB105 recognizes the CD44 antigen. CD44 is a marker for many types of cancer stem cells (CSC), including breast CSCs that possess higher tumorigenicity and metastatic potential, colorectal, pancreatic, and prostate CSCs. In addition, expression was observed in several cancers as well as on carcinoma cell lines. Here, CD44 plays a role in cancer cell migration and matrix adhesion in response to a cellular microenvironment, thus enhancing cellular aggregation and tumor cell growth. CD44 is also expressed on mesodermal cells, such as hematopoietic, fibroblastic, and glial cells. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134272 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
Cd44-Fitc 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 556af0e0-edd0-4b42-924f-7747c44688dc 35 fields · synced May 30, 2026