AccessGUDID - DEVICE: Vysis (00884999025745)

GUDID

Device Identifier (DI) Information

Brand Name: Vysis
Version or Model: 06N38-020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06N38-020
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999025745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Vysis ALK Break Apart FISH Probe 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?
60088	Anaplastic lymphoma kinase (ALK) 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 genetic mutations of the anaplastic lymphoma kinase (ALK) gene, also known as ALK gene. The changes detected at the gene or chromosome level may include ALK gene rearrangement, or NPM-ALK or EML4-ALK fusion genes formed by translocation.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110012	001
P110012	002
P110012	003
P110012	004
P110012	005
P110012	006
P110012	007
P110012	008
P110012	009
P110012	011
P110012	012
P110012	013
P110012	014
P110012	015
P110012	016
P110012	017

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
Storage Environment Temperature: between -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78a76e44-2d19-4add-b7e4-0c54cd2b4a4b
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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