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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
KLK10 in Texas Red Spectrum FDA UDI
Model / Reference
MPP1132 FDA UDI
Description
KLK10 in Texas Red Spectrum FDA UDI

Identifiers

Primary DI / UDI-DI
05055844913127 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 are innovative, assay development analyte-specific reagents used in laboratory developed tests (LDTs) and commercial in vitro diagnostic medical devices (IVDs). Designed to identify or quantify specific targets in biological specimens, these probes provide reliable results for various clinical applications.

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 850343b9-7042-4b40-a41a-1e8ab47612d0 35 fields · synced Jul 18, 2026