FDA.reportPublic FDA data

Vysis

Primary DI
00884999044210
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
08N85-005
Catalog number
08N85-005
Device description
Vysis IntelliFISH Universal FFPE Tissue Pretreatment and Wash Reagents
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDTREAGENT, GENERAL PURPOSE
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDTREAGENT, GENERAL PURPOSE
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999044210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999044210008849990442108849990442100884999044210

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
Premarket exempt
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
00846405012282Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012299Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012367Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012374Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012381Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012398Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012404Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012480Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014095Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014132Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014217Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014224Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405016716Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017065Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017072Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017089Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017362Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405019298Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023233Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023257Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023264Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023318Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023325Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023974Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405024421Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07