← Back to catalogue

Accula Programming Cassette

FDA UDI

Class N (US FDA UDI)

by Mesa Biotech, Inc.

Identity

Trade Name
Accula Programming Cassette FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Device Name
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware FDA UDI
Model / Reference
D2001 FDA UDI
Description
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware FDA UDI

Identifiers

Catalog Number
D2001 FDA UDI
Primary DI / UDI-DI
B540D20010 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 Programming Cassette 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mesa Biotech, Inc.

Sources (1)

  • FDA UDI ec9b032d-3f1f-458d-ac69-602c3e6d9ccb 36 fields · synced Jun 6, 2026