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Cfx96

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
CFX96 FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
CFX96 Dx and CFX96 Deep Well Dx Systems FDA UDI
Model / Reference
1844095-IVD FDA UDI
Description
CFX96 Dx and CFX96 Deep Well Dx Systems FDA UDI

Identifiers

Catalog Number
1844095-IVD FDA UDI
Primary DI / UDI-DI
03610520550984 FDA UDI
FDA Product Code
NSU FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory 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

Yes

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

Cfx96 by Bio-Rad Laboratories — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 1c097758-8206-4c95-8317-16b008c350ec 36 fields · synced May 30, 2026