FDA.reportPublic FDA data

DiskFISH

Primary DI
M663DF400599
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
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
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

Contacts#

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

Regulatory Flags#

DUNS number
831148692
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
M663DF400590DiskFISHDF40059DF400592026-01-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
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00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
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00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
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00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22