AccessGUDID - DEVICE: PathVysion (00884999001756)

GUDID

Device Identifier (DI) Information

Brand Name: PathVysion
Version or Model: 02J01-035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02J01-035
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999001756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: PathVysion HER-2 DNA 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?
57050	Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVD	SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980024	001
P980024	002
P980024	003
P980024	004
P980024	005
P980024	006
P980024	007
P980024	008
P980024	009
P980024	010
P980024	011
P980024	012
P980024	014
P980024	015
P980024	016
P980024	017
P980024	018
P980024	019
P980024	020

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: 84c4fdb0-449a-428e-8eff-67fcc035424f
Public Version Date: February 06, 2025
Public Version Number: 5
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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