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Lyfo Disk™

FDA UDI

Class I (US FDA UDI)

by Microbiologics, Inc.

Identity

Trade Name
LYFO DISK™ FDA UDI
Generic Name
Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
Device Name
LYFO DISK™ P. acidilactici ATCC 8042™ FDA UDI
Model / Reference
0259L FDA UDI
Description
LYFO DISK™ P. acidilactici ATCC 8042™ FDA UDI

Identifiers

Catalog Number
0259L FDA UDI
Primary DI / UDI-DI
10845357004632 FDA UDI
FDA Product Code
JTR FDA UDI
GMDN Term
Multiple bacteria species culture isolate identification control IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2480 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 bacteria species culture isolate identification control IVD, kit

Lyfo Disk™ by Microbiologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microbiologics, Inc.

Sources (1)

  • FDA UDI 12539711-c8ed-4b14-b232-7662dca3dddc 36 fields · synced Jun 8, 2026