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Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Primus Corp.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Multiple haemoglobin subtype IVD, reagent FDA UDI
Device Name
Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL FDA UDI
Model / Reference
Mobile Phase 2 Reagent - 940mL FDA UDI
Description
Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL FDA UDI

Identifiers

Catalog Number
01-03-0044 FDA UDI
Primary DI / UDI-DI
05391516744263 FDA UDI
510(k) Number
K955283 FDA UDI
FDA Product Code
GKA FDA UDI
GMDN Term
Multiple haemoglobin subtype IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7415 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 940 Milliliter FDA UDI

Category: Multiple haemoglobin subtype IVD, reagent

Trinity Biotech by Primus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple haemoglobin subtype IVD, reagent.

Cleared under the same submission

K955283 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Primus Corp.

Sources (1)

  • FDA UDI 5bb61022-3a3b-49b8-8da6-80f556f84201 38 fields · synced May 30, 2026