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Savanna

FDA UDI

Class II (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
Savanna FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Device Name
Savanna Instrument FDA UDI
Model / Reference
20382 FDA UDI
Description
Savanna Instrument FDA UDI

Identifiers

Catalog Number
20382 FDA UDI
Primary DI / UDI-DI
30014613339304 FDA UDI
510(k) Number
K232286 FDA UDI
FDA Product Code
OOI FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Savanna by Diagnostic Hybrids, 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, point-of-care.

Cleared under the same submission

K232286 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI 6f6f9451-3c0e-4366-83f0-709bc2afccad 36 fields · synced May 30, 2026