FDA.reportPublic FDA data

Immunalysis

Primary DI
00840937108307
Brand
Immunalysis
Company
IMMUNALYSIS CORP
Model
10009-15
Catalog number
10009-15
Device description
Opiates Urine Calibrator 2000, 3
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DIFDrug mixture control materials
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937108307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937108307008409371083078409371083070840937108307

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite 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 opiate and/or opiate 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
002804244
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840937114636Immunalysis10063-1510063-152024-04-19
00840937114643Immunalysis10064-1510064-152024-04-19
00840937114650Immunalysis10065-1510065-152024-04-19
00840937114667Immunalysis10066-1510066-152024-04-19
00840937114674Immunalysis3020-153020-152024-04-19
00840937114568Immunalysis10068-1510068-152024-04-08
00840937114605ImmunalysisNegOFLP-0100NegOFLP-01002024-04-08
00840937103265Immunalysis10047-1010047-102023-10-26
00840937103272Immunalysis10048-1010048-102023-10-26
00840937103289Immunalysis10049-1010049-102023-10-26
00840937103296Immunalysis10050-1010050-102023-10-26
00840937112076Immunalysis3017-103017-102021-02-05
00840937112083Immunalysis10054-1010054-102021-02-05
00840937112090Immunalysis10053-1010053-102021-02-05
00840937112106Immunalysis10052-1010052-102021-02-05
00840937112113Immunalysis10051-1010051-102021-02-05
00840937111895Immunalysis10055-1010055-102020-03-31
00840937111918Immunalysis10056-1010056-102020-03-31
00840937111925Immunalysis10057-1010057-102020-03-31
00840937111932Immunalysis10058-1010058-102020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B07609730LZI Fentanyl Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2026-07-17
00690286000742MEDTOX®MEDTOX DIAGNOSTICS, INC.DIF2026-03-31
00812101031629ARK™ Ketamine II CalibratorARK DIAGNOSTICS INCDLJ2025-12-27
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
00850624008650LZI Fentanyl Qualitative CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2025-10-13
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00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
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00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
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00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
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00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
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00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12