FDA.report

Immunalysis Corporation

Primary DI
00840937108307
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
10009-15
Device description
Immunalysis Corporation Opiates Urine Calibrator 2000 Level 3 - 1000 ng/mL (15 mL)
Published
2016-09-13
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

Related Records

Product Codes

CodeName
DIFDrug mixture control materials
DLJCalibrators, Drug Specific

Product Code Classifications

CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937108307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937108307008409371083078409371083070840937108307

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

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

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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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