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Savanna

FDA UDI

Class II (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
Savanna FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Device Name
Savanna HSV 1+2/VZV Control Set FDA UDI
Model / Reference
M409-4 FDA UDI
Description
Savanna HSV 1+2/VZV Control Set FDA UDI

Identifiers

Catalog Number
M409-4 FDA UDI
Primary DI / UDI-DI
30014613340492 FDA UDI
510(k) Number
K232286 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 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: Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Savanna by Diagnostic Hybrids, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, control.

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 60634c2e-169c-4df2-aca8-9da2d9025dd2 36 fields · synced Jun 1, 2026