FDA.report

Hydrophilic Plus Slides

Primary DI
B502BSB70280
Brand
Hydrophilic Plus Slides
Company
BIO SB, INC.
Model
BSB 7028
Catalog number
BSB 7028
Device description
The Hydrophilic Plus Microscope Slides are novel positively charged hydrophilic slides that prevent tissue detachment after thermal permeabilization and can be used to mount and process IHC, ICC, FISH and CISH samples including those to be subjected to Heat -Induced Epitope Retrieval (HIER) procedures.
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB70280PrimaryHIBCC0

GMDN Terms

TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)561-1145sales@biosb.com

Regulatory Flags

DUNS number
102855447
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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