FDA.report

ihcDirect® CDX2 Ab Conjugate 5mL

Primary DI
00850030934857
Brand
ihcDirect® CDX2 Ab Conjugate 5mL
Company
NOVODIAX, INC.
Model
H32047-R005
Catalog number
K32047-005
Device description
Clone R1014
Published
2021-08-20
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

Related Records

Contact Domains

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850000596870PreviousGS10
00850030934857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000596870008500005968708500005968700850000596870
00850030934857008500309348578500309348570850030934857

GMDN Terms

TermDefinition
Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homeobox protein CDX-2, also referred to as caudal-type homeobox protein 2, in a clinical specimen, using an enzyme immunohistochemistry method.

Device Sizes

TypeValueUnit
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature21 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
5103423043support@novodiax.com

Regulatory Flags

DUNS number
965326957
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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