Syva® Emit® 2000 Phenytoin Assay

Primary DI
00842768017384
Brand
Syva® Emit® 2000 Phenytoin Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445303
Catalog number
4A019UL
Device description
Emit ® 2000 Phenytoin 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
DIPENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIPEnzyme Immunoassay, DiphenylhydantoinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913429000EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORSSyva Co.1991-08-26DIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768017384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768017384008427680173848427680173840842768017384

GMDN Terms#

Term, Definition table
TermDefinition
Phenytoin 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 central nervous system drug phenytoin (e.g., dilantin) 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
+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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