FDA.reportPublic FDA data

Syva® Emit® 2000 Phenobarbital Calibrators

Primary DI
00842768017414
Brand
Syva® Emit® 2000 Phenobarbital Calibrators
Company
Siemens Healthcare Diagnostics Inc.
Model
10445307
Catalog number
4D109UL
Device description
Syva® Emit® 2000 Phenobarbital Calibrators
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
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913190000EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORSSyva Co.1991-08-26DLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768017414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768017414008427680174148427680174140842768017414

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of phenobarbital in a clinical specimen.

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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