FDA.reportPublic FDA data

Syva® Emit® Ethosuximide Assay

Primary DI
00842768000140
Brand
Syva® Emit® Ethosuximide Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445367
Catalog number
6E119UL
Device description
Syva® Emit® Ethosuximide 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
DLFENZYME IMMUNOASSAY, ETHOSUXIMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLFEnzyme Immunoassay, EthosuximideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832797000MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.1983-09-29DLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768000140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768000140008427680001408427680001400842768000140

GMDN Terms#

Term, Definition table
TermDefinition
Ethosuximide 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 ethosuximide 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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