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Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP

FDA UDI

Class I (US FDA UDI)

by Memed Diagnostics Ltd

Identity

Trade Name
Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP FDA UDI
Generic Name
Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid FDA UDI
Device Name
The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. FDA UDI
Model / Reference
FG00004 FDA UDI
Description
The Performance Verification Kit contains a set of serum-based quantitative samples intended for manual use by healthcare professionals as a reference material to verify the analytical performance (precision, accuracy, and reportable range) of tests based on quantification of TRAIL/ IP-10/ CRP protein concentrations via the MeMed Key® analyzer platform. The performance verification kit is intended for in vitro diagnostic use only. FDA UDI

Identifiers

Primary DI / UDI-DI
17290018739072 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

FDA UDI

Combination Product

No

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HCT/P

No

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

No

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP by Memed Diagnostics Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Memed Diagnostics Ltd

Sources (1)

  • FDA UDI 4c7fdec2-8e78-4d79-a159-7991dad2c976 34 fields · synced Jun 7, 2026