FDA.reportPublic FDA data

STRATIFY JCV™ DXSELECT™

Primary DI
20816101022261
Brand
STRATIFY JCV™ DXSELECT™
Company
DIASORIN MOLECULAR LLC
Model
EL1950-5
Catalog number
EL1950-5
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYPAnti-Jcv Antibody Detection Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYPAnti-Jcv Antibody Detection AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120986000STRATIFY JCV DXSELECTFocus Diagnostics, Inc.2012-08-16OYP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101022261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102226120816101022261

GMDN Terms#

Term, Definition table
TermDefinition
JC virus (JCV) antigen 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 antigens from JC virus (JCV) 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
562-240-6500DxTs@focusdx.com
562-240-6500TS.Molecular@DiaSorin.com

Regulatory Flags#

DUNS number
080271715
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20816101020243Rickettsia IFA IgGIF0100GIF0100G2026-03-13
20816101020250Rickettsia IFA IgMIF0100MIF0100M2026-03-13
20816101020342Q Fever IFA IgGIF0200GIF0200G2026-03-13
20816101020359Q Fever IFA IgMIF0200MIF0200M2026-03-13
20816101020397Arbovirus IFA IgGIF0300GIF0300G2026-03-13
20816101020403Arbovirus IFA IgMIF0300MIF0300M2026-03-13
20816101025538Simplexa™ Flu A/B & RSVMOL2600MOL26002016-09-22
20816101025507Simplexa™ HSV 1 & 2 DirectMOL2150MOL21502016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackMOL2160MOL21602016-09-22
10816101025142LIAISON NES® InstrumentNES1001NES10012026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)NES1001RNES1001R2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19NES4450NES44502026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitNES4460NES44602026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectMOL4450MOL44502026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackMOL4460MOL44602026-01-14
10816101020772R. rickettsii Substrate SlideIF0102IF01022025-12-16
10816101027375Blastomyces Primer PairMOL9206MOL92062025-12-16
20816101027136Simplexa COVID-19 Positive Control GEN II Pack MOL4165MOL41652025-09-17
10816101025005Integrated Cyler (110V)MOL1001MOL10012016-09-24
10816101025012Integrated Cyler (110V) Pre-OwnedMOL1001-PMOL1001-P2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745002231IMMUNOWELL JCV IgG TestGenBioOYP2025-08-29
20816101022254STRATIFY JCV™ DXSELECT™DIASORIN MOLECULAR LLCOYP2016-09-22