FDA.reportPublic FDA data

Syva® Emit® 2000 Theophylline Assay

Primary DI
00842768001024
Brand
Syva® Emit® 2000 Theophylline Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445324
Catalog number
4P019UL
Device description
Syva® Emit® 2000 Theophylline Assay
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
KLSENZYME IMMUNOASSAY, THEOPHYLLINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLSEnzyme Immunoassay, TheophyllineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913123000EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORSSyva Co.1991-09-19KLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768001024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768001024008427680010248427680010240842768001024

GMDN Terms#

Term, Definition table
TermDefinition
Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen, using and 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
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147931ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2020-03-05
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00630414596006Atellica CH TheoSiemens Healthcare Diagnostics Inc.KLS2017-12-22
05055273206432THEORANDOX LABORATORIES LIMITEDKLS2016-09-24
00842768001031Syva® Emit® 2000 Theophylline CalibratorsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768001413Syva® Emit® Caffeine AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768005664Dimension® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768015458Dimension Vista® Flex® reagent cartridge THEOSiemens Healthcare Diagnostics Inc.KLS2016-09-24
00842768023286Emit® 2000 Theophylline AssaySiemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460918ADVIA Centaur® Systems Calibrator 27Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460956ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414460963ADVIA Centaur® THEO 2Siemens Healthcare Diagnostics Inc.KLS2016-09-24
00630414561905ADVIA® Chemistry THEO_2 Theophylline_2 ReagentsSiemens Healthcare Diagnostics Inc.KLS2016-09-24
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00630414966571IMMULITE®/IMMULITE® 1000 Systems THE TheophyllineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLS2016-09-24
04015630997169ONLINE TDM TheophyllineRoche Diagnostics GmbHKLS2016-09-20
04015630999934TheophyllineRoche Diagnostics GmbHKLS2016-09-20
00884883001275CEDIA Theophylline II AssayMicrogenics CorporationKLS2016-09-12
10758750004706VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
10758750008759VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KLS2016-08-26
15099590232078SynchronBeckman Coulter, Inc.KLS2016-08-24
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