FDA.reportPublic FDA data

goldFISH

Primary DI
00810202560505
Brand
goldFISH
Company
Lumatas Biosystems, Inc.
Model
DF032
Device description
C11ORF95 Dual Color Break Apart Probe
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810202560505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810202560505008102025605058102025605050810202560505

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-510-651-8890info@lumatas.com

Regulatory Flags#

DUNS number
080169635
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810202560406goldFISHDF0102025-11-18
00810202560413goldFISHDF0112025-11-18
00810202560420goldFISHDF0122025-11-18
00810202560437goldFISHDF0222025-11-18
00810202560444goldFISHDF0232025-11-18
00810202560451goldFISHDF0242025-11-18
00810202560468goldFISHDF0282025-11-18
00810202560475goldFISHDF0292025-11-18
00810202560482goldFISHDF0302025-11-18
00810202560499goldFISHDF0312025-11-18
00810202560512goldFISHDF0332025-11-18
00810202560529goldFISHDF0482025-11-18
00810202560536goldFISHDF0492025-11-18
00810202560543goldFISHDF0522025-11-18
00810202560550goldFISHDF0532025-11-18
00810202560567goldFISHDF0542025-11-18
00810202560574goldFISHDF0562025-11-18
00810202560581goldFISHDF0612025-11-18
00810202560598goldFISHDF0632025-11-18
00810202560604goldFISHDF0742025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05