FDA.reportPublic FDA data

Novocastra™

Primary DI
05055331315106
Brand
Novocastra™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
CD10-270-L-CE
Catalog number
NCL-L-CD10-270
Device description
NCL-L-CD10-270 is intended for the qualitative identification by light microscopy of human CD10 molecules in paraffin sections.
Published
2021-04-16
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
05055331315106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331315106050553313151065055331315106

GMDN Terms#

Term, Definition table
TermDefinition
CD10 cell marker 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 CD10 cell marker 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
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
08718858481613Kreatech FISH probes14Q001B5502022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-05-18
00847627051622CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00846405000005Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000012Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000029Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00847627040664SALL4BIOCARE MEDICAL LLCNJT2026-04-01
00847627041036Cyclin D1BIOCARE MEDICAL LLCNJT2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})BIOCARE MEDICAL LLCNJT2026-04-01
00847627042194Caspase-3 (Cleaved)BIOCARE MEDICAL LLCNJT2026-04-01
00847627042590S100PBIOCARE MEDICAL LLCNJT2026-04-01
00847627042859CD33BIOCARE MEDICAL LLCNJT2026-04-01
07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.NJT2026-03-26
00847627041500Uroplakin II + Uroplakin IIIBIOCARE MEDICAL LLCNJT2025-11-19
00847627041845SOX11 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042156CDH17 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042552Epithelial Membrane Antigen (EMA) [E29] BIOCARE MEDICAL LLCNJT2025-11-19
00847627042675CDX2 (RM)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042736IgG4 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627040640p53BIOCARE MEDICAL LLCNJT2025-11-10
00847627041975DOG1BIOCARE MEDICAL LLCNJT2025-11-10
00847627042811CD19 (RM) [RM332]BIOCARE MEDICAL LLCNJT2025-10-31
00847627041562Glutamine SynthetaseBIOCARE MEDICAL LLCNJT2025-10-23
00847627041609Cytokeratin 17 (CK17)BIOCARE MEDICAL LLCNJT2025-10-23
07613336234365VENTANA HER2 (CAL27) AssayVentana Medical Systems, Inc.NJT2025-10-21
00847627041821Lambda Light Chain [N10/2]BIOCARE MEDICAL LLCNJT2025-10-21
00847627041883Cytokeratin 5 (CK5)BIOCARE MEDICAL LLCNJT2025-10-21
07613336234433TRPS1 (SP532) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2025-10-16
00847627040008HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10
00847627040015HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10