FDA.report

Immunalysis Corporation

Primary DI
00840937110812
Brand
Immunalysis Corporation
Company
IMMUNALYSIS CORPORATION
Model
608OF-0100
Device description
Immunalysis Corporation SEFRIA PCP Oral Fluid Kit 100
Published
2018-04-20
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

Contact Domains

Product Codes

CodeName
LCMEnzyme immunoassay, phencyclidine
PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Product Code Classifications

CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU
PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection DeviceClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840937110812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937110812008409371108128409371108120840937110812

GMDN Terms

TermDefinition
Phencyclidine (PCP) 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 phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
909-482-0840info@immunalysis.com
+1(909)482-0840info@immunalysis.com

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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