FDA.reportPublic FDA data

Kreatech FISH probes

Primary DI
08718858481279
Brand
Kreatech FISH probes
Company
Kreatech Biotechnology B.V.
Model
08Q007V495
Published
2022-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, specific, analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718858481279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718858481279087188584812798718858481279

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, probeA 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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+(31)206919181CustomerService.Amsterdam@leicabiosystems.com

Regulatory Flags#

DUNS number
406381124
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718858480791Kreatech FISH probes22Q003B495 2022-09-21
08718858481231Kreatech FISH probes02P009V550 2022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V495 2022-09-21
08718858481668Kreatech FISH probes03Q001B550 2022-08-08
08718858481675Kreatech FISH probes03Q002B495 2022-08-08
08718858481712Kreatech FISH probes13Q002C495 2022-08-08
08718858481729Kreatech FISH probes14Q001C415 2022-08-08
08718858481736Kreatech FISH probes16Q001B495 2022-08-08
08718858481743Kreatech FISH probes23P004C550 2022-08-08
08718858481798Kreatech FISH probes04Q001B550 2022-08-08
08718858481804Kreatech FISH probes04Q005B550 2022-08-08
08718858481811Kreatech FISH probes08C001B495 2022-08-08
08718858481880Kreatech FISH probes01P003B550 2022-08-08
08718858481958Kreatech FISH probes04C001B495 2022-08-08
08718858480029Kreatech FISH probes06Q003B495 2022-08-05
08718858480036Kreatech FISH probes10Q001B495 2022-08-05
08718858481613Kreatech FISH probes14Q001B550 2022-08-04
08718858481569Kreatech FISH probesKI-20011B 2022-08-03
08718858481576Kreatech FISH probesKI-20015B 2022-08-03

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