FDA.report

Immunalysis Corporation

Primary DI
00840937108918
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
10001-15
Device description
Immunalysis Corporation Multi-Drug Calibrator Level 2 (15 mL)
Published
2016-12-27
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
DKBCalibrators, drug mixture

Product Code Classifications

CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937108918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937108918008409371089188409371089180840937108918

GMDN Terms

TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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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