FDA.reportPublic FDA data

Vysis

Primary DI
00884999042780
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
04N02-021
Catalog number
04N02-021
Device description
Vysis CLL FISH Probe Kit
Published
2016-04-17
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
PNKFluorescence in situ hybridization, chromosome 17p deletion (TP53)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNKFluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150041000
P150041001
P150041002
P150041003
P150041004
P150041005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150041000VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK
P150041001VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK
P150041002VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK
P150041003VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK
P150041004VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK
P150041005VYSIS CLL FISH PROBE KITAbbott Molecular, Inc.2016-04-11PNK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999042780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999042780008849990427808849990427800884999042780

GMDN Terms#

Term, Definition table
TermDefinition
Chronic lymphocytic leukaemia (CLL) 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 chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 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