← Back to catalogue

Trinity Biotech

FDA UDI

Class I (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Coverslips, 70x22 mm, 12 each FDA UDI
Model / Reference
90-1700 FDA UDI
Description
Coverslips, 70x22 mm, 12 each FDA UDI

Identifiers

Catalog Number
90-1700 FDA UDI
Primary DI / UDI-DI
05391516747929 FDA UDI
FDA Product Code
KES FDA UDI
LHL FDA UDI
LSR FDA UDI
GMDN Term
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
866.3300 FDA UDI
866.3830 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

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

No

FDA UDI

Category: Legionella pneumophila total antibody IVD, kit, fluorescent immunoassayBorrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay

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

Similar devices

Also classified as Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay.

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 77efe890-9d48-4f50-a8a5-ba2bca6bc352 36 fields · synced May 30, 2026