FDA.report

Immunalysis Corporation

Primary DI
00840937107829
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
3006-5
Device description
Immunalysis Corporation EDDP Specific Urine Control Set 1, 2 x 5mL ea.
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

Related Records

Product Codes

CodeName
LASDrug specific control materials

Product Code Classifications

CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937107829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937107829008409371078298409371078290840937107829

GMDN Terms

TermDefinition
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, controlA material which is used to verify the performance of 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

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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