FDA.reportPublic FDA data

Immunalysis Corporation

Primary DI
00840937103906
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
C340UR-5-1
Device description
Immunalysis Corporation Ketamine Urine Calibrator
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
00840937103906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937103906008409371039068409371039060840937103906

GMDN Terms#

Term, Definition table
TermDefinition
Ketamine/ketamine metabolite IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative detection of ketamine and/or ketamine metabolites 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
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
00840937103265Immunalysis Corporation10047-1010047-102023-10-26
00840937103272Immunalysis Corporation10048-1010048-102023-10-26
00840937103289Immunalysis Corporation10049-1010049-102023-10-26
00840937103296Immunalysis Corporation10050-1010050-102023-10-26
00840937103302Immunalysis Corporation3018-103018-102023-10-26
00840937111864Immunalysis Corporation647OF-0100647OF-01002023-10-25
00840937111871Immunalysis Corporation647OF-0500647OF-05002023-10-25
00840937112007Immunalysis Corporation609OF-0100609OF-01002023-10-25
00840937112014Immunalysis Corporation609OF-0500609OF-05002023-10-25
00840937103142Immunalysis QS-76501QS-765012023-03-29
00840937112120SEFRIA™612OF-01002021-09-30
00840937112137SEFRIA™612OF-05002021-09-30
00840937112076Immunalysis Corporation3017-103017-102021-02-05
00840937112083Immunalysis Corporation10054-1010054-102021-02-05
00840937112090Immunalysis Corporation10053-1010053-102021-02-05
00840937112106Immunalysis Corporation10052-1010052-102021-02-05
00840937112113Immunalysis Corporation10051-1010051-102021-02-05
00840937112175Immunalysis Corporation324OF-0100 324OF-0100 2021-02-01
00840937112182Immunalysis Corporation324OF-0500 324OF-0500 2021-02-01
00840937112052QuantisalQSI-POUCHQSI-POUCH2020-10-06