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Accula Dock

FDA UDI

Class N (US FDA UDI)

by Mesa Biotech, Inc.

Identity

Trade Name
Accula Dock FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Device Name
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette. FDA UDI
Model / Reference
D2000 FDA UDI
Description
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette. FDA UDI

Identifiers

Catalog Number
D2000 FDA UDI
Primary DI / UDI-DI
B540D20000 FDA UDI
FDA Product Code
QJR FDA UDI
OZE FDA UDI
OCC FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI

Classification

Device Class
N FDA UDI
Regulation Number
866.3980 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Accula Dock by Mesa Biotech, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermal cycler nucleic acid amplification analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mesa Biotech, Inc.

Sources (1)

  • FDA UDI 7774b47e-c438-4567-9bf7-aa769e5e7b32 36 fields · synced May 30, 2026