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Simplexa™ C. auris Positive Control Pack

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
Simplexa™ C. auris Positive Control Pack FDA UDI
Generic Name
Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
MOL3960 FDA UDI

Identifiers

Catalog Number
MOL3960 FDA UDI
Primary DI / UDI-DI
20816101027211 FDA UDI
510(k) Number
DEN230092 FDA UDI
FDA Product Code
SBT FDA UDI
GMDN Term
Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3967 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

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

No

FDA UDI

Category: Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ C. auris Positive Control Pack by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

DEN230092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI a9a10e39-0190-45f4-83be-5c136144b34c 36 fields · synced Jun 9, 2026