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Azure Cielo Dx

FDA UDI

Class II (US FDA UDI)

by Azure Biosystems Inc.

Identity

Trade Name
Azure Cielo Dx FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI
Model / Reference
Azure Cielo 3 Dx FDA UDI

Identifiers

Primary DI / UDI-DI
00860006465605 FDA UDI
FDA Product Code
NSU FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Azure Cielo Dx by Azure Biosystems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Azure Biosystems Inc.

Sources (1)

  • FDA UDI d76c568d-a1bc-48fd-bce4-5e530414c2cf 32 fields · synced Jun 8, 2026