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HardyDisk™

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
HardyDisk™ FDA UDI
Generic Name
Multiple anaerobic bacteria species culture isolate differentiation disc IVD FDA UDI
Device Name
Colistin, 10mcg, CT, for the differentiation of anaerobic bacteria based on susceptibility to Colistin, 1 x 50 disks, used as an aid in clarifying gram stain reaction of anaerobes, and in preliminary grouping of anaerobic gram-negative bacilli. FDA UDI
Model / Reference
Z8411 FDA UDI
Description
Colistin, 10mcg, CT, for the differentiation of anaerobic bacteria based on susceptibility to Colistin, 1 x 50 disks, used as an aid in clarifying gram stain reaction of anaerobes, and in preliminary grouping of anaerobic gram-negative bacilli. FDA UDI

Identifiers

Catalog Number
Z8411 FDA UDI
Primary DI / UDI-DI
00816576029136 FDA UDI
FDA Product Code
JTO FDA UDI
GMDN Term
Multiple anaerobic bacteria species culture isolate differentiation disc IVD 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 anaerobic bacteria species culture isolate differentiation disc IVD

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

Similar devices

Also classified as Multiple anaerobic bacteria species culture isolate differentiation disc IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI ea7c81a9-0482-4fab-814e-4ed95dbcb227 36 fields · synced May 31, 2026