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Cd57-Fitc

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
CD57-FITC FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
TB03 recognizes the human CD57. CD57, also known as HNK-1 or Leu-7, is an antigenic Oligosaccharide moiety detected on extracellular proteins of certain cell types. In blood, CD57 is found on 15-20% of mononuclear cells, including subsets of NK and T cells, though not on erythrocytes, monocytes, granulocytes, or platelets. Also, CD57 expression can be found on a variety of neural cell types. CD57 has been shown to be expressed on late stage effector CD8+ T cells. The frequency of CD57+ T lymphocytes is raised in a variety of diseases. CD57 expression is also increased on chronically activated CD8+ T cells in persistent viral infections, such as HIV. FDA UDI
Model / Reference
170-081-025 FDA UDI
Description
TB03 recognizes the human CD57. CD57, also known as HNK-1 or Leu-7, is an antigenic Oligosaccharide moiety detected on extracellular proteins of certain cell types. In blood, CD57 is found on 15-20% of mononuclear cells, including subsets of NK and T cells, though not on erythrocytes, monocytes, granulocytes, or platelets. Also, CD57 expression can be found on a variety of neural cell types. CD57 has been shown to be expressed on late stage effector CD8+ T cells. The frequency of CD57+ T lymphocytes is raised in a variety of diseases. CD57 expression is also increased on chronically activated CD8+ T cells in persistent viral infections, such as HIV. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934134340 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

Cd57-Fitc 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Miltenyi Biotec B.V. & Co. KG

Sources (1)

  • FDA UDI b4f24102-80ff-48d6-a1ee-7258d81538ab 35 fields · synced May 30, 2026