FluoroMounter

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: FluoroMounter FDA UDI
Generic Name: Microscopy mounting medium IVD FDA UDI
Device Name: FluoroMounter is an aqueous mounting media used for mounting cells or tissue sections stained by Immunofluorescence or FISH for the preservation of fluorescence staining. FDA UDI
Model / Reference: 100 ml FDA UDI
Description: FluoroMounter is an aqueous mounting media used for mounting cells or tissue sections stained by Immunofluorescence or FISH for the preservation of fluorescence staining. FDA UDI

Identifiers

Catalog Number: BSB 0159 FDA UDI
Primary DI / UDI-DI: B502BSB01590 FDA UDI
FDA Product Code: PPM FDA UDI
GMDN Term: Microscopy mounting medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Microscopy mounting medium IVD

FluoroMounter by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microscopy mounting medium IVD.

Tissue-Tek® Glas™ — Sakura Finetek USA, Inc · Class I
ClaraMount™ Coverslip mounting medium — Clarapath, Inc. · Class I
Mounting medium (IIFT) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
Mounting medium (IIFT) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
India Ink — MICROBIOLOGICS, INC. · Class I
IMMUNO CONCEPTS Substrate Slide Test Systems — IMMUNO CONCEPTS INC
Fluoro Care Anti-Fade Mountant — BIOCARE MEDICAL, LLC · Class I
Genemed® — Sakura Finetek USA, Inc · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI 44c2855e-27a3-491a-b9ea-77d9de14bd32 34 fields · synced May 30, 2026