ihcDirect® E-Cadherin Ab, 15mL

Primary DI
00850000596917
Brand
ihcDirect® E-Cadherin Ab, 15mL
Company
NOVODIAX, INC.
Model
K32036-015
Device description
Clone R1005
Published
2021-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850000596917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000596917008500005969178500005969170850000596917

GMDN Terms#

Term, Definition table
TermDefinition
E-cadherin epithelial marker IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of E-cadherin epithelial marker in a clinical specimen, using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature21 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5103423043support@novodiax.com

Regulatory Flags#

DUNS number
965326957
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00850036867760Q-STAIN® QSX-Enh-F WT-1QF32045-004QF32045-0042023-11-21
00850036867777Q-STAIN® QSX-Enh-P Gal-3QP32025-004QP32025-0042023-11-21
00850036867784Q-STAIN® QSX-Enh-F Gal-3QF32025-004QF32025-0042023-11-21
00850036867791Q-STAIN® QSX-Enh-P TROP2QP32044-004QP32044-0042023-11-21
00850036867807Q-STAIN® QSX-Enh-F TROP2QF32044-004QF32044-0042023-11-21
00850041202365Q-STAIN® QSX-Enh-F CgAQF32035-004QF32035-0042023-11-21
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00850036867234Q-STAIN® QSX-Enh-F Ki67 QF32001-004QF32001-0042022-07-21

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