FDA.report

CytoLayer Slide treatment Solution

Primary DI
B502BSB40320
Brand
CytoLayer Slide treatment Solution
Company
BIO SB, INC.
Model
1000 ml
Catalog number
BSB 4032
Device description
The CytoLayer Slide Treatment Solution is intended to be used to treat the Hydrophylic Plus Slides prior to sedimentation of liquid cytology samples. This treatment significantly improves adherence of cells to the slide surface and is critical for reliable processing of liquid cytology samples.
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB40320PrimaryHIBCC0

GMDN Terms

TermDefinition
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.

Sterilization Methods

Method

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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