AccessGUDID - DEVICE: CytoCell (05055844923898)

GUDID

Device Identifier (DI) Information

Brand Name: CytoCell
Version or Model: USA-LPH026
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYTOCELL LIMITED

Primary DI Number: 05055844923898
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 232477914 *Terms of Use
Previous DI: 05055844905900

Device Description: AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit (IVD (USA))

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:	No
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?
60079	Acute myeloid leukaemia (AML) 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 acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QDI	Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170070	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: between -25 and -15 Degrees Celsius
Special Storage Condition, Specify: Store the probe vial in the dark. Ensure that exposure of the probe to laboratory lights is limited at all times.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a6d4114-599a-4479-bafb-30f2ecf91ec0
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025

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: 914 467 5285
Email: contact@ogt.com

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