AccessGUDID - DEVICE: Vysis (00884999001848)

GUDID

Device Identifier (DI) Information

Brand Name: Vysis
Version or Model: 02J05-010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02J05-010
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999001848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: ProbeChek PATHVISION HER-2/neu Normal Control Slides

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?
57049	Human epidermal growth factor receptor 2 (HER2) protein IVD, control	A material which is used to verify the performance of an assay intended to be 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
NTH	System, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN040010	000

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: Store the ProbeChek PATHVYSION HER-2/neu Normal Control Slides in tightly sealed container with desiccant to protect them from humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0a5fab5-7693-4be6-8605-7a3cd4c99223
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 01, 2016

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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