FDA.reportPublic FDA data

Vysis

Primary DI
00884999001848
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
02J05-010
Catalog number
02J05-010
Device description
ProbeChek PATHVISION HER-2/neu Normal Control Slides
Published
2016-09-01
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
NTHSystem, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) AssaysImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN040010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN040010000VYSIS AUTOVYSION SYSTEMVysis2004-12-13NTH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999001848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999001848008849990018488849990018480884999001848

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the ProbeChek PATHVYSION HER-2/neu Normal Control Slides in tightly sealed container with desiccant to protect them from humidity
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
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NTH2024-07-02
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NTH2022-03-21
07290016630015GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.NTH2018-01-25
07290016630008GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.NTH2017-01-12
00884999001824VysisABBOTT MOLECULAR INC.NTH2016-09-01
07290107652780Duet™BIO-VIEW LTDNTH2016-08-14
07290107652797Duet™BIO-VIEW LTDNTH2016-08-14
07290107652803Duet™BIO-VIEW LTDNTH2016-08-14
07290107652810Duet™BIO-VIEW LTDNTH2016-08-14
07290107652827Duet™BIO-VIEW LTDNTH2016-08-14
07290107652902Duet™BIO-VIEW LTDNTH2016-08-14
07290107652919Duet™BIO-VIEW LTDNTH2016-08-14
07290107652926Duet™BIO-VIEW LTDNTH2016-08-14
07290107652933Duet™BIO-VIEW LTDNTH2016-08-14
07290107652940Duet™BIO-VIEW LTDNTH2016-08-14
07290107652971Duet™BIO-VIEW LTDNTH2016-08-14
07290107653039Duet™BIO-VIEW LTDNTH2016-08-14
07290107653053Duet™BIO-VIEW LTDNTH2016-08-14
07290107653060Duet™BIO-VIEW LTDNTH2016-08-14
07290107653077Duet™BIO-VIEW LTDNTH2016-08-14
07290107653091Duet™BIO-VIEW LTDNTH2016-08-14
07290107653206Duet™BIO-VIEW LTDNTH2016-08-14
07290107653213Duet™BIO-VIEW LTDNTH2016-08-14
07290107653237Duet™BIO-VIEW LTDNTH2016-08-14
07290107653244Duet™BIO-VIEW LTDNTH2016-08-14
07290107653251Duet™BIO-VIEW LTDNTH2016-08-14
07290107652773Duet™BIO-VIEW LTDNTH2016-07-27