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Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Trinity Biotech Public Limited Company

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (50 Tests) FDA UDI
Model / Reference
345-B FDA UDI
Description
Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (50 Tests) FDA UDI

Identifiers

Catalog Number
345-B FDA UDI
Primary DI / UDI-DI
05391516745680 FDA UDI
510(k) Number
K790211 FDA UDI
FDA Product Code
JBL FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7360 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

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: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

Trinity Biotech by Trinity Biotech Public Limited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry.

Cleared under the same submission

K790211 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trinity Biotech Public Limited Company

Sources (1)

  • FDA UDI 467b6af4-906a-4ee4-bd9d-7684f13d78ac 38 fields · synced Jun 1, 2026