← Back to catalogue

HardyDisk™

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
HardyDisk™ FDA UDI
Generic Name
Multiple-type meningitis pathogen nucleic acid IVD, reagent FDA UDI
Device Name
Caffeic Acid Disks, for Cryptococcus, 25 disks per pack HardyDisk™ Caffeic Acid Disks detect the ability of an organism to produce the enzyme phenyloxidase, which is useful for the identification of Cryptococcus neoformans and Cryptococcus gattii. FDA UDI
Model / Reference
Z118 FDA UDI
Description
Caffeic Acid Disks, for Cryptococcus, 25 disks per pack HardyDisk™ Caffeic Acid Disks detect the ability of an organism to produce the enzyme phenyloxidase, which is useful for the identification of Cryptococcus neoformans and Cryptococcus gattii. FDA UDI

Identifiers

Catalog Number
Z118 FDA UDI
Primary DI / UDI-DI
00819398028578 FDA UDI
FDA Product Code
JTO FDA UDI
GMDN Term
Multiple-type meningitis pathogen nucleic acid IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-type meningitis pathogen nucleic acid IVD, reagent

HardyDisk™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI 9d6199e6-6ada-4d77-919a-ae907289a20d 36 fields · synced Jun 6, 2026