FDA.reportPublic FDA data

Immunalysis Corporation

Primary DI
00840937111086
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
04W31-03
Catalog number
04W31-03
Device description
Immunalysis Corporation EDDP Specific Urine Calibrator Level 3 - 500 ng/mL
Published
2018-06-29
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

Product Codes#

Code, Name table
CodeName
DLJCalibrators, drug specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937111086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937111086008409371110868409371110860840937111086

GMDN Terms#

Term, Definition table
TermDefinition
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812101031636ARK™ Ketamine II Calibrator (Negative)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
07613336224830MTX CalibratorRoche Diagnostics GmbHDLJ2024-03-25
00840937103265Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103272Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103289Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103296Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
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00812101030516ARK™ HS Benzodiazepine II Negative CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030523ARK™ HS Benzodiazepine II 100ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030530ARK™ HS Benzodiazepine II 200ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
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