← Back to catalogue

Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Uni-Gold™ Giardia Control, Giardia Positive and Negative Control, 1 Positive and 1 Negative FDA UDI
Model / Reference
1206611 FDA UDI
Description
Uni-Gold™ Giardia Control, Giardia Positive and Negative Control, 1 Positive and 1 Negative FDA UDI

Identifiers

Catalog Number
1206611 FDA UDI
Primary DI / UDI-DI
05391516746335 FDA UDI
510(k) Number
K120001 FDA UDI
FDA Product Code
MHI FDA UDI
GMDN Term
Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) 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: Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K120001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mardx Diagnostics, Inc.

Sources (1)

  • FDA UDI 1155eab3-78f4-410d-9e2c-87808c02ce95 37 fields · synced Jun 1, 2026