FDA.reportPublic FDA data

Immunalysis Corporation

Primary DI
00840937103081
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
346-0500EX
Device description
Immunalysis Corporation K2 (Synthetic Cannabinoids-2) HEIA Kit 500
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937103081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937103081008409371030818409371030810840937103081

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of synthetic cannabinoids and/or synthetic cannabinoid metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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
00840937106389Immunalysis CorporationFC-209-252016-08-31
00840937106396Immunalysis CorporationFC-209-602016-08-31
00840937106402Immunalysis CorporationFC-209-7502016-08-31
00840937106419Immunalysis CorporationFC-210-252016-08-31
00840937106426Immunalysis CorporationFC-210-602016-08-31