FDA.reportPublic FDA data

Immunalysis

Primary DI
00840937110829
Brand
Immunalysis
Company
IMMUNALYSIS CORP
Model
608OF-0500
Catalog number
608OF-0500
Device description
SEFRIA™ PCP Oral Fluid
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203489000SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2021-04-20LCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937110829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937110829008409371108298409371108290840937110829

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-482-0840info@immunalysis.com
+1(909)482-0840info@immunalysis.com

Regulatory Flags#

DUNS number
002804244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840937114636Immunalysis10063-1510063-152024-04-19
00840937114643Immunalysis10064-1510064-152024-04-19
00840937114650Immunalysis10065-1510065-152024-04-19
00840937114667Immunalysis10066-1510066-152024-04-19
00840937114674Immunalysis3020-153020-152024-04-19
00840937114568Immunalysis10068-1510068-152024-04-08
00840937114605ImmunalysisNegOFLP-0100NegOFLP-01002024-04-08
00840937103265Immunalysis10047-1010047-102023-10-26
00840937103272Immunalysis10048-1010048-102023-10-26
00840937103289Immunalysis10049-1010049-102023-10-26
00840937103296Immunalysis10050-1010050-102023-10-26
00840937112076Immunalysis3017-103017-102021-02-05
00840937112083Immunalysis10054-1010054-102021-02-05
00840937112090Immunalysis10053-1010053-102021-02-05
00840937112106Immunalysis10052-1010052-102021-02-05
00840937112113Immunalysis10051-1010051-102021-02-05
00840937111895Immunalysis10055-1010055-102020-03-31
00840937111918Immunalysis10056-1010056-102020-03-31
00840937111925Immunalysis10057-1010057-102020-03-31
00840937111932Immunalysis10058-1010058-102020-03-31

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