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TrinityBiotech

FDA UDI

Class II (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
TrinityBiotech FDA UDI
Generic Name
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot FDA UDI
Device Name
Uni-Gold™ Cryptosporidium, 20 Tests FDA UDI
Model / Reference
1206620 FDA UDI
Description
Uni-Gold™ Cryptosporidium, 20 Tests FDA UDI

Identifiers

Catalog Number
1206620 FDA UDI
Primary DI / UDI-DI
05391516746342 FDA UDI
510(k) Number
K121565 FDA UDI
FDA Product Code
MHJ FDA UDI
GMDN Term
Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

TrinityBiotech by Mardx Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot.

Cleared under the same submission

K121565 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mardx Diagnostics, Inc.

Sources (1)

  • FDA UDI 57cd71b8-3ab6-443d-883b-46392eff871b 37 fields · synced Jun 1, 2026