FDA.report

Vysis

Primary DI
00884999010703
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
05J05-001
Catalog number
05J05-001
Device description
Vysis ToTelVysion MultiColor FISH Probe
Published
2017-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MVUREAGENTS,SPECIFIC,ANALYTE

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884999010703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999010703008849990107038849990107030884999010703

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature0-20 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags

DUNS number
878263359
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
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 DIBrandModelCatalogPublished
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26
30884999051400simpli-COLLECT09N93-00109N93-0012025-06-26
00884999050662Alinity m09N85-07509N85-0752025-05-30
00884999050686Alinity m09N85-08509N85-0852025-05-30
00884999050709Alinity m09N85-09509N85-0952025-05-30
00884999050945Alinity m09N85-05A09N85-05A2025-05-30
00884999048973Alinity mp09N65-00709N65-0072025-05-28
00884999051508Alinity mp09N65-2109N65-212025-05-28
00884999051515Alinity mp09N65-2209N65-222025-05-28
00884999051720Alinity mp09N65-2309N65-232025-05-28
00884999051065Alinity m09N46-05B09N46-05B2024-02-22
00884999050570Alinity m1.0009N61-03A2024-07-26
00884999050587Alinity m09N61-08509N61-0852024-07-26
00884999050594Alinity m09N61-09509N61-0952024-07-27
00884999047884Alinity m09N50-00109N50-0012020-05-20
00884999048928Alinity mp09N65-00209N65-0022024-04-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
04251315801035MetaSystems ProbesMetaSystems Probes GmbHMVU2026-03-17
05055844935525CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935532CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935549CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935556CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935563CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935617CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935624CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
00850051429936Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-02-26
00850051429882Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
00850051429899Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1AGILENT TECHNOLOGIES, INC.MVU2026-01-21
M663DF300120DiskFISHCELLAY, INC.MVU2026-01-06
M663DF300129DiskFISHCELLAY, INC.MVU2026-01-06
M663DF400590DiskFISHCELLAY, INC.MVU2026-01-06
M663DF402440DiskFISHCELLAY, INC.MVU2026-01-06
M663CKOF300120OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF302510OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF400590OligoFISHCELLAY, INC.MVU2026-01-06
M663OF4005903001OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF402440OligoFISHCELLAY, INC.MVU2026-01-06
00810034704009PE anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704016FITC anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704047Pacific Blue™ anti-human Granzyme BBIOLEGEND, INC.MVU2025-12-22
00810034704054Spark Violet™ 538 anti-human HLA-DRBIOLEGEND, INC.MVU2025-12-22