FDA.reportPublic FDA data

Immunalysis Corporation

Primary DI
00840937106389
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
FC-209-25
Device description
Immunalysis Corporation Amphetamine Conjugate (25 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
00840937106389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937106389008409371063898409371063890840937106389

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 qualitative and/or quantitative detection of a specific amphetamine 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
080589004
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
00840937112151QuantisalQSI-0025QSI-00252020-08-31
00840937112168QuantisalQSI-0500QSI-05002020-08-31
00840937105986Immunalysis CorporationCP-2372016-08-31
00840937106006Immunalysis CorporationCP-2392016-08-31
00840937106020Immunalysis CorporationCP-2422016-08-31
00840937106266Immunalysis CorporationFC-206-602016-08-31
00840937106280Immunalysis CorporationFC-207-152016-08-31
00840937106297Immunalysis CorporationFC-207-252016-08-31
00840937106303Immunalysis CorporationFC-207-602016-08-31
00840937106310Immunalysis CorporationFC-207-7502016-08-31
00840937106334Immunalysis CorporationFC-207B-602016-08-31
00840937106341Immunalysis CorporationFC-207B-7502016-08-31
00840937106358Immunalysis CorporationFC-208-252016-08-31
00840937106365Immunalysis CorporationFC-208-602016-08-31
00840937106372Immunalysis CorporationFC-208-7502016-08-31
00840937106396Immunalysis CorporationFC-209-602016-08-31
00840937106402Immunalysis CorporationFC-209-7502016-08-31
00840937106419Immunalysis CorporationFC-210-252016-08-31
00840937106426Immunalysis CorporationFC-210-602016-08-31
00840937106433Immunalysis CorporationFC-210-7502016-08-31