FDA.reportPublic FDA data

Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator

Primary DI
00842768001475
Brand
Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10445377
Catalog number
6R319UL
Device description
Emit ® 2000 Cyclosporine Specific Negative Calibrator
Published
2016-09-24
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
MKWCYCLOSPORINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKWCyclosporineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920031000EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYDade Behring, Inc.1996-10-02MKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768001475PrimaryGS10
00630414024523Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768001475008427680014758427680014750842768001475
00630414024523006304140245236304140245230630414024523

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-70 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
3
Lot or batch
true
Expiration date on label
true

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00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
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00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
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00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
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00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869164000079Emit Cyclosporine SampleFUJIREBIO DIAGNOSTICS, INC.MKW2023-12-06
00380740168209Alinity-ArchitectABBOTT LABORATORIESMKW2019-06-14
00630414598727Atellica IM CsASiemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598741Atellica IM Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598765Atellica IM CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2018-02-06
00842768001451Syva® Emit® 2000 Cyclosporine Specific AssaySiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001468Syva® Emit® 2000 Cyclosporine Specific CalibratorsSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001482Syva® Emit® Cyclosporine Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768005268Dimension® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768015144Dimension Vista® Flex® reagent cartridge CSASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768016035Dimension Vista® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768025136Dimension® CSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00884883011861CEDIA Cyclosporine-PLUS AssayMicrogenics CorporationMKW2016-09-24
00630414524450ADVIA Centaur® CsASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414524474ADVIA Centaur® CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414525549ADVIA Centaur® Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2016-09-24
04015630997459CSAII Cyclosporine IIRoche Diagnostics GmbHMKW2016-09-20
00884883001589CEDIA Cyclosporine PLUS AssayMicrogenics CorporationMKW2016-09-12
00380740081911ARCHITECTABBOTT LABORATORIESMKW2016-09-09
00380740001308ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001315ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001322ARCHITECTABBOTT LABORATORIESMKW2016-06-06