FDA.report

ihcDirect® Galectin-3 Ab Conjugate 5mL

Primary DI
00850030934772
Brand
ihcDirect® Galectin-3 Ab Conjugate 5mL
Company
NOVODIAX, INC.
Model
H32025-R005
Catalog number
K32025-005
Device description
Clone R105
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
00850000596788PreviousGS10
00850030934772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000596788008500005967888500005967880850000596788
00850030934772008500309347728500309347720850030934772

GMDN Terms

TermDefinition
Galectin-3 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 galectin-3 protein in a clinical specimen.

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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