FDA.reportPublic FDA data

Vysis

Primary DI
00884999025745
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
06N38-020
Catalog number
06N38-020
Device description
Vysis ALK Break Apart FISH Probe Kit
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene RearrangementUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110012001
P110012002
P110012003
P110012004
P110012005
P110012006
P110012007
P110012008
P110012009
P110012011
P110012012
P110012013
P110012014
P110012015
P110012016
P110012017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110012001VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012002VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012003VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012004VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012005VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012006VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012007VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012008VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012009VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012011VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012013VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012014VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012015VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012016VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE
P110012017VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKAbbott Molecular, Inc.2011-08-26OWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999025745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999025745008849990257458849990257450884999025745

GMDN Terms#

Term, Definition table
TermDefinition
Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probeA defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in 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
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature-30 Degrees Celsius-10 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
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
00884999025721VysisABBOTT MOLECULAR INC.OWE2014-11-20
00884999025738VysisABBOTT MOLECULAR INC.OWE2014-11-20