FDA.reportPublic FDA data

Novocastra

Primary DI
05055331321107
Brand
Novocastra
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
P57-L-U
Catalog number
NCL-L-P57-U
Device description
NCL-L-p57-U is intended for the qualitative identification by light microscopy of human p57protein, also known as Kip2 protein, in parrafin sections.
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055331321107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331321107050553313211075055331321107

GMDN Terms#

Term, Definition table
TermDefinition
P57 protein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of p57 protein, also known as Kip2 or cyclin-dependent kinase inhibitor 1C (CDK1C), in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags#

DUNS number
397134693
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055331330581BOND-PRIMECS9300CS93002026-07-08
05055331339607BONDPA0678-UPA0678-U2026-04-10
05055331316967Novocastra™AE1/AE3-L-CENCL-L-AE1/AE32022-12-07
08718858480791Kreatech FISH probes22Q003B4952022-09-21
08718858481231Kreatech FISH probes02P009V5502022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V4952022-09-21
08718858481668Kreatech FISH probes03Q001B5502022-08-08
08718858481675Kreatech FISH probes03Q002B4952022-08-08
08718858481712Kreatech FISH probes13Q002C4952022-08-08
08718858481729Kreatech FISH probes14Q001C4152022-08-08
08718858481736Kreatech FISH probes16Q001B4952022-08-08
08718858481743Kreatech FISH probes23P004C5502022-08-08
08718858481798Kreatech FISH probes04Q001B5502022-08-08
08718858481804Kreatech FISH probes04Q005B5502022-08-08
08718858481811Kreatech FISH probes08C001B4952022-08-08
08718858481880Kreatech FISH probes01P003B5502022-08-08
08718858481958Kreatech FISH probes04C001B4952022-08-08
08718858480029Kreatech FISH probes06Q003B4952022-08-05
08718858480036Kreatech FISH probes10Q001B4952022-08-05

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Primary DI, Brand, Company table
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