VP2000

Contact Domains#

Code, Name table
Code	Name
OWE	Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Code, Device, Specialty table
Code	Device	Specialty	Class
OWE	Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement	Unknown	3

Submission, Supplement table
Submission	Supplement
P110012	009

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P110012	009	VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK	Abbott Molecular, Inc.	2011-08-26	OWE

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00884999038189	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00884999038189	00884999038189	884999038189	0884999038189

Term, Definition table
Term	Definition
Nucleic acid hybridization detection IVD, reagent	A 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)].

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	-30 Degrees Celsius	8 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

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00085412531212	VERITAS COLLAGEN MATRIX	SYNOVIS LIFE TECHNOLOGIES, INC.	OWE	2015-10-05
00085412531236	VERITAS COLLAGEN MATRIX	SYNOVIS LIFE TECHNOLOGIES, INC.	OWE	2015-10-05
00085412531250	VERITAS COLLAGEN MATRIX	SYNOVIS LIFE TECHNOLOGIES, INC.	OWE	2015-10-05
00085412531274	VERITAS COLLAGEN MATRIX	SYNOVIS LIFE TECHNOLOGIES, INC.	OWE	2015-10-05
00884999042728	Vysis	ABBOTT MOLECULAR INC.	OWE	2015-07-31
00884999042773	Vysis	ABBOTT MOLECULAR INC.	OWE	2015-07-31
00884999000735	Vysis	ABBOTT MOLECULAR INC.	OWE	2014-11-20
00884999025721	Vysis	ABBOTT MOLECULAR INC.	OWE	2014-11-20
00884999025738	Vysis	ABBOTT MOLECULAR INC.	OWE	2014-11-20
00884999025745	Vysis	ABBOTT MOLECULAR INC.	OWE	2014-11-20