Identity
- Trade Name
- CD94-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA113 recognizes CD94, an approximately 45 kDa, single pass, type II transmembrane protein, which belongs to C-type lectin superfamily. CD94 associates covalently with NKG2 family members and forms disulfide-bonded heterodimers. CD94-NKG2 receptors bind HLA-E, the non-classical MHC class Ib molecule. Depending on the associated NKG2 member, CD94-NKG2 heterodimer transmits either activating or inhibitory signal. For example, via immunoreceptor tyrosine–based inhibitory motifs (ITIMs) containing NKG2A, CD94-NKG2A heterodimers inhibit NK cell cytotoxicity. Besides NK cells, expression of CD94-NKG2 heterodimers is also shown on NK-T cells and a small percentage of CD8 cells in mice, where the crosslinking of CD94-NKG2 was shown to reduce the level of spontaneous apoptosis. Additional Information: Clone REA113 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-033 FDA UDI
- Description
- REA113 recognizes CD94, an approximately 45 kDa, single pass, type II transmembrane protein, which belongs to C-type lectin superfamily. CD94 associates covalently with NKG2 family members and forms disulfide-bonded heterodimers. CD94-NKG2 receptors bind HLA-E, the non-classical MHC class Ib molecule. Depending on the associated NKG2 member, CD94-NKG2 heterodimer transmits either activating or inhibitory signal. For example, via immunoreceptor tyrosine–based inhibitory motifs (ITIMs) containing NKG2A, CD94-NKG2A heterodimers inhibit NK cell cytotoxicity. Besides NK cells, expression of CD94-NKG2 heterodimers is also shown on NK-T cells and a small percentage of CD8 cells in mice, where the crosslinking of CD94-NKG2 was shown to reduce the level of spontaneous apoptosis. Additional Information: Clone REA113 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134265 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
Cd94-Apc 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 883285aa-4234-4b7f-ad06-a178c07fe593 35 fields · synced May 30, 2026