Kreatech FISH probes

Basic Information

• Brand Name: Kreatech FISH probes
• Primary DI: 08718858480708
• Version / Model: 08Q002I550
• Company Name: Kreatech Biotechnology B.V.
• Labeler DUNS: 406381124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-22
• Public Version: 1
• Public Version Date: 2022-08-01
• Public Version Status: New
• Public Device Record Key: 4eba1cf8-d3e1-435e-ac66-3224f26ff78f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, specific, analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61199	Nucleic acid hybridization detection IVD, probe	A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718858480708	GS1

Customer Contacts

• Phone: +(31)206919181
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius