FDA.reportPublic FDA data

UroVysion

Primary DI
00884999002180
Brand
UroVysion
Company
ABBOTT MOLECULAR INC.
Model
02J27-095
Catalog number
02J27-095
Device description
UroVysion Bladder Cancer Kit
Published
2014-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSDTest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For RecurrenceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030052001
P030052002
P030052003
P030052004
P030052005
P030052006
P030052007
P030052008
P030052009
P030052010
P030052011
P030052012
P030052013
P030052014
P030052015
P030052016
P030052017
P030052018
P030052019
P030052020
P030052021
P030052022
P030052023
P030052024
P030052025
P030052026

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030052001UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052002UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052003UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052004UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052005UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052006UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052007UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052008UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052009UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052010UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052011UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052012UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052013UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052014UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052015UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052016UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052017UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052018UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052019UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052020UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052021UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052022UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052023UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052024UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052025UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24
P030052026UROVYSION BLADDER CANCER KITAbbott Molecular2005-01-24

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999002180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999002180008849990021808849990021800884999002180

GMDN Terms#

Term, Definition table
TermDefinition
Bladder tumour-associated 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 one or multiple acquired mutations e.g., of chromosome 3, 7 and 17, associated with bladder cancer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from light and humidity
Storage Environment Temperature-20 Degrees Celsius-20 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999002142UroVysionABBOTT MOLECULAR INC.NSD2014-11-20