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CytoCell myProbes

FDA UDI

Class I (US FDA UDI)

by Cytocell, Ltd.

Identity

Trade Name
CytoCell myProbes FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
8cen in FITC Spectrum FDA UDI
Model / Reference
MPP0123 FDA UDI
Description
8cen in FITC Spectrum FDA UDI

Identifiers

Primary DI / UDI-DI
05055844912885 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Assay development analyte-specific reagent IVD

CytoCell myProbes is a high-quality, laboratory-developed test (LDT) or commercial in vitro diagnostic medical device (IVD) designed for the detection of specific antibodies or receptors in biological specimens. MyProbes are ideal for applications where precise and accurate diagnosis is critical, and the use of an antibody-specific reagent allows for a high degree of specificity and sensitivity.

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
Cytocell, Ltd.

Sources (1)

  • FDA UDI 2ccd62dc-9c80-4450-88df-496f24330c4a 35 fields · synced Aug 3, 2026