FDA.report

Immunalysis Corporation

Primary DI
00840937109366
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
ASR-E-320-600
Device description
Immunalysis Corporation Meperidine Enzyme Conjugate ASR 600 mL
Published
2017-01-11
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
MVUReagents, specific, analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937109366PrimaryGS10

GMDN Terms

TermDefinition
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.

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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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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