Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Primus Corp.

Identity

Trade Name: Trinity Biotech FDA UDI
Generic Name: Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Device Name: Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer FDA UDI
Model / Reference: Premier Hb9210 HbA1c Analyzer - 1 each FDA UDI
Description: Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer FDA UDI

Identifiers

Catalog Number: 09-00-0001 FDA UDI
Primary DI / UDI-DI: 05391516744751 FDA UDI
FDA Product Code: LCP FDA UDI
GMDN Term: Glycated haemoglobin (HbA1C) analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glycated haemoglobin (HbA1C) analyser IVD

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

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D-100 — Bio-Rad Laboratories · Class I
D-10 — Bio-Rad Laboratories · Class I
D-10 — Bio-Rad Laboratories · Class I
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Primus Corp.

Sources (1)

FDA UDI 938669ef-09f3-40e7-91df-423858df2567 36 fields · synced May 30, 2026