Vysis

Contact Domains#

Code, Name table
Code	Name
PFG	DNA FISH probe Kit for specimen characterization, human chromosome, hematological disorders

Code, Device, Specialty table
Code	Device	Specialty	Class
PFG	Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders	Hematology	2

Submission, Supplement table
Submission	Supplement
K131508	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K131508	000	VYSIS D7S486/CEP 7 FISH PROBE KIT	Abbott Molecular, Inc.	2013-09-13	PFG

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00884999036406	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00884999036406	00884999036406	884999036406	0884999036406

Term, Definition table
Term	Definition
Acute myeloid leukaemia (AML) genetic mutation IVD, probe	A 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 acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Vysis D7S486/CEP 7 FISH Probe Kit must be stored to protect from light when not in use. The NP - 40 and 20X SSC salt may be stored separately at room temperature.
Storage Environment Temperature	-25 Degrees Celsius	-15 Degrees Celsius

Method table
Method

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

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00884999051287	Alinity m	09N15-03B	09N15-03B	2026-04-13
00884999051690	simpli-COLLECT	09R16-001	09R16-001	2026-04-13
00884999052062	Alinity m	09N61-03B	09N61-03B	2025-11-20
00884999047846	Alinity m	09N26-001	09N26-001	2020-04-29
00884999047853	Alinity m	09N26-002	09N26-002	2020-04-29
00884999047860	Alinity m	09N26-010	09N26-010	2020-04-29
00884999047426	Alinity m	09N26-012	09N26-012	2020-04-29
00884999047440	Alinity m	09N26-014	09N26-014	2020-04-29
00884999047464	Alinity m	09N26-016	09N26-016	2020-04-29
00884999047501	Alinity m	09N26-004	09N26-004	2020-04-29
00884999048096	Alinity m	09N26-019	09N26-019	2020-04-29
00884999048171	Alinity m	09N26-020	09N26-020	2020-04-29
00884999048034	Alinity m	08N53-002	08N53-002	2020-08-18
00884999031814	m2000	9K15-01	9K15-01	2016-09-01
00884999049369	Alinity m	09N79-095	09N79-095	2025-06-27
00884999049376	Alinity m	09N79-085	09N79-085	2025-06-27
00884999049383	Alinity m	09N79-03A	09N79-03A	2025-06-27
00884999051348	simpli-COLLECT	09R02-001	09R02-001	2025-06-26
00884999051409	simpli-COLLECT	09N93-001	09N93-001	2025-06-26
30884999051349	simpli-COLLECT	09R02-001	09R02-001	2025-06-26