← Back to catalogue

Monofluo

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
MONOFLUO FDA UDI
Generic Name
Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Device Name
MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test FDA UDI
Model / Reference
32515 FDA UDI
Description
MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test FDA UDI

Identifiers

Catalog Number
32515 FDA UDI
Primary DI / UDI-DI
00847865001519 FDA UDI
510(k) Number
K890768 FDA UDI
FDA Product Code
LYF FDA UDI
GMDN Term
Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3780 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

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: Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

Monofluo by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT).

Cleared under the same submission

K890768 also covers:

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
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 8e59ef7c-0f02-43b5-81ab-3d1cd584975c 38 fields · synced Jun 1, 2026