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FluoroMounter with DAPI

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
FluoroMounter with DAPI FDA UDI
Generic Name
DAPI solution IVD FDA UDI
Device Name
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining. FDA UDI
Model / Reference
1000 ml FDA UDI
Description
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining. FDA UDI

Identifiers

Catalog Number
BSB 0168 FDA UDI
Primary DI / UDI-DI
B502BSB01680 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
DAPI solution 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: DAPI solution IVD

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

Similar devices

Also classified as DAPI solution IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI 53cb20a8-8e6f-4c9f-bc91-4b892350f0c0 34 fields · synced May 30, 2026