Vysis

Contact Domains#

Code, Name table
Code	Name
OYU	Dna-probe kit, human chromosome

Code, Device, Specialty table
Code	Device	Specialty	Class
OYU	Dna-Probe Kit, Human Chromosome	Immunology	2

Submission, Supplement table
Submission	Supplement
K010288	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K010288	000	ANEUVYSION MULITICOLOR DNA PROBE KIT	Vysis	2001-04-13	OYU

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00884999011663	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00884999011663	00884999011663	884999011663	0884999011663

Term, Definition table
Term	Definition
Multiple congenital aneuploidy screening IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies.

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	The Probechek Control Slides should be stored in a sealed container with desiccant to protect from humidity
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

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00884999027077	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-10
00884999011694	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999011700	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999011717	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999011731	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999027008	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999027039	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999027046	Vysis	ABBOTT MOLECULAR INC.	OYU	2016-09-01
00884999001831	PathVysion	ABBOTT MOLECULAR INC.	OYU	2014-11-20
00884999001855	PathVysion	ABBOTT MOLECULAR INC.	OYU	2014-11-20
00884999002128	UroVysion	ABBOTT MOLECULAR INC.	OYU	2014-11-20
00884999025721	Vysis	ABBOTT MOLECULAR INC.	OYU	2014-11-20
00884999025738	Vysis	ABBOTT MOLECULAR INC.	OYU	2014-11-20