FDA.reportPublic FDA data

Simplexa™ Spectral Calibration Panel

Primary DI
20816101025101
Brand
Simplexa™ Spectral Calibration Panel
Company
DIASORIN MOLECULAR LLC
Model
SC1100
Catalog number
SC1100
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1023140003M INTEGRATED CYCLER (110V) & (220V)Focus Diagnostics, Inc.2010-10-29OOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102510120816101025101

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument calibration/verification reference standard IVDA solid phase or sealed liquid reference standard of known optical and physical characteristics, intended to be used to verify the performance of a spectrophotometer or other optical instrument. The standard is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a source of light emitted at specified wavelengths. Verification functions may include optical density (absorbance), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 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