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CLA-1™ Luminometer

FDA UDI

Class II (US FDA UDI)

by Minaris Medical America, Inc.

Identity

Trade Name
CLA-1™ Luminometer FDA UDI
Generic Name
Chemiluminescent immunoassay analyser IVD, semi-automated FDA UDI
Device Name
CLA-1 Luminometer FDA UDI
Model / Reference
95019 FDA UDI
Description
CLA-1 Luminometer FDA UDI

Identifiers

Catalog Number
95019 FDA UDI
Primary DI / UDI-DI
00813382010044 FDA UDI
FDA Product Code
DHB FDA UDI
GMDN Term
Chemiluminescent immunoassay analyser IVD, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5750 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD, semi-automated

CLA-1™ Luminometer by Minaris Medical America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemiluminescent immunoassay analyser IVD, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Minaris Medical America, Inc.

Sources (1)

  • FDA UDI e6537bc3-1b8e-4a23-9e76-8c5ae234a495 35 fields · synced May 30, 2026