FDA.reportPublic FDA data

DiskFISH

Primary DI
M663DF400590
Brand
DiskFISH
Company
CELLAY, INC.
Model
DF40059
Catalog number
DF40059
Device description
DiskFISH Disks (3Gd, 6A, 7Gr, 20R)
Published
2026-01-06
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M663DF4005901001PrimaryHIBCC0
M663DF400599PrimaryHIBCC0
M663DF400590Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, probeA defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6172717003customer.support@cellayinc.com

Regulatory Flags#

DUNS number
831148692
Device count
50
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M663DF3001201001DiskFISHDF3-0012-0100DF3-0012-01002026-01-06
M663DF4005901001DiskFISHDF4-0059-0100DF4-0059-01002026-01-06
M663DF400599DiskFISHDF40059DF400592026-01-06
M663DF4024401001DiskFISHDF4-0244-0100DF4-0244-01002026-01-06
M663DF402449DiskFISHDF40244DF402442026-01-06
M663OF3001201001OligoFISHOF3-0012-0100OF3-0012-01002026-01-06
M663OF3025101001OligoFISHOF3-0251-0100OF3-0251-01002026-01-06
M663OF4005901001OligoFISHOF4-0059-0100OF4-0059-01002026-01-06
M663OF4024401001OligoFISHOF4-0244-0100OF4-0244-01002026-01-06
M663DF300120DiskFISHDF3-0012-0100DF3-0012-01002026-01-06
M663DF300129DiskFISHDF30012DF300122026-01-06
M663DF402440DiskFISHDF40244DF402442026-01-06
M663CKOF300120OligoFISHOF3-0012-0100OF3-0012-01002026-01-06
M663CKOF302510OligoFISHOF3-0251-0100OF3-0251-01002026-01-06
M663CKOF400590OligoFISHOF4-0059-0100OF4-0059-01002026-01-06
M663OF4005903001OligoFISHOF4-0059-0300OF4-0059-03002026-01-06
M663CKOF402440OligoFISHOF4-0244-0100OF4-0244-01002026-01-06

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