FDA.reportPublic FDA data

Vysis

Primary DI
00884999025738
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
06N38-010
Catalog number
06N38-010
Device description
ProbeChek ALK Positive Control Slides
Published
2014-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWEFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
OYUDna-probe kit, human chromosome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene RearrangementUnknown3
OYUDna-Probe Kit, Human ChromosomeImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999025738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999025738008849990257388849990257380884999025738

GMDN Terms#

Term, Definition table
TermDefinition
Anaplastic lymphoma kinase (ALK) genetic mutation IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict genetic mutations of the anaplastic lymphoma kinase (ALK) gene, also known as ALK gene. The changes detected at the gene or chromosome level may include ALK gene rearrangement, or NPM-ALK or EML4-ALK fusion genes formed by translocation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999027077VysisABBOTT MOLECULAR INC.OYU2016-09-10
00884999011663VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999011694VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999011700VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999011717VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999011731VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999027008VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999027039VysisABBOTT MOLECULAR INC.OYU2016-09-01
00884999027046VysisABBOTT MOLECULAR INC.OYU2016-09-01
00085412531212VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.OWE2015-10-05
00085412531236VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.OWE2015-10-05
00085412531250VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.OWE2015-10-05
00085412531274VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.OWE2015-10-05
00884999038189VP2000ABBOTT MOLECULAR INC.OWE2015-07-31
00884999042728VysisABBOTT MOLECULAR INC.OWE2015-07-31
00884999042773VysisABBOTT MOLECULAR INC.OWE2015-07-31
00884999000735VysisABBOTT MOLECULAR INC.OWE2014-11-20
00884999001831PathVysionABBOTT MOLECULAR INC.OYU2014-11-20
00884999001855PathVysionABBOTT MOLECULAR INC.OYU2014-11-20
00884999002128UroVysionABBOTT MOLECULAR INC.OYU2014-11-20
00884999025721VysisABBOTT MOLECULAR INC.OWE2014-11-20
00884999025721VysisABBOTT MOLECULAR INC.OYU2014-11-20
00884999025745VysisABBOTT MOLECULAR INC.OWE2014-11-20