AccessGUDID - DEVICE: UroVysion (00884999002180)

GUDID

Device Identifier (DI) Information

Brand Name: UroVysion
Version or Model: 02J27-095
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02J27-095
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999002180
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: UroVysion Bladder Cancer Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61101	Bladder tumour-associated 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 one or multiple acquired mutations e.g., of chromosome 3, 7 and 17, associated with bladder cancer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSD	Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030052	001
P030052	002
P030052	003
P030052	004
P030052	005
P030052	006
P030052	007
P030052	008
P030052	009
P030052	010
P030052	011
P030052	012
P030052	013
P030052	014
P030052	015
P030052	016
P030052	017
P030052	018
P030052	019
P030052	020
P030052	021
P030052	022
P030052	023
P030052	024
P030052	025
P030052	026

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect from light and humidity
Storage Environment Temperature: exactly -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e51d3b0-4700-49b8-b69e-4ee77f1dcfdd
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: November 20, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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