FDA.reportPublic FDA data

ImmuKnow

Primary DI
00863651000306
Brand
ImmuKnow
Company
VIRACOR-IBT LABORATORIES, INC.
Model
4400
Device description
Immune cell function assay kit.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIDAssay, Proliferation, In Vitro, T Lymphocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIDAssay, Proliferation, In Vitro, T LymphocyteHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863651000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863651000306008636510003068636510003060863651000306

GMDN Terms#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8162510415CustomerCare@viracoribt.com

Regulatory Flags#

DUNS number
125886114
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true