AccessGUDID - DEVICE: Vysis (00884999027046)

GUDID

Device Identifier (DI) Information

Brand Name: Vysis
Version or Model: 07J21-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07J21-002
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999027046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: ProbeChek Positive Control 10% Trisomy 8/12

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?
61685	Cancer/tumour-associated aneuploidy 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 evaluate a clinical specimen to diagnose, monitor or predict one or multiple acquired aneuploidies associated with cancer, such as aneuploidies of chromosome 3, 7, and 17 (associated with bladder cancer) or chromosome 8 and 12 [associated with B-cell chronic lymphocytic leukaemia (CLL) and myeloid disorders such as chronic myeloid leukaemia (CML) and acute myeloid leukaemia (AML)], in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVQ	Chronic lymphocytic leukemia fish probe kit
OYU	Dna-probe kit, human chromosome
KIR	CELLS, ANIMAL AND HUMAN, CULTURED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953591	000
K962873	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
Storage Environment Temperature: exactly -20 Degrees Celsius
Special Storage Condition, Specify: Store ProbeChek Control Slides in a sealed container with desiccant to protect from humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8f374b8-966a-49f4-8c39-e54e95bdc048
Public Version Date: July 06, 2018
Public Version Number: 3
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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