FDA.reportPublic FDA data

Immunalysis Corporation

Primary DI
00840937106631
Brand
Immunalysis Corporation
Company
ALERE INC.
Model
FC-219-60
Device description
Immunalysis Corporation Methylphenidate Conjugate (60 mL)
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937106631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937106631008409371066318409371066310840937106631

GMDN Terms#

Term, Definition table
TermDefinition
Multiple catecholamine IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple catecholamines which may include adrenalin (epinephrine), noradrenalin (norepinephrine) and/or dopamine, in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093803398
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840937100370Immunalysis Corporation219-00962016-08-31
00840937100387Immunalysis Corporation219-04802016-08-31
00840937100394Immunalysis Corporation219-48002016-08-31
00840937105443Immunalysis CorporationCB-4192016-08-31
00840937106624Immunalysis CorporationFC-219-152016-08-31
00840937106648Immunalysis CorporationFC-219-7502016-08-31