TD TRICYC ANTIDEPRESSANT ASSAY, TCA

Primary DI
00630414595849
Brand
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Company
Siemens Healthcare Diagnostics Inc.
Model
11097528
Catalog number
11097528
Device description
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Published
2018-12-01
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
LFHU.V. Spectrometry, tricyclic antidepressant drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFHU.V. Spectrometry, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961393000TRICYCLICS SERUM TOX ASSAYDiagnostic Reagents, Inc.1996-06-12LFH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414595849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414595849006304145958496304145958490630414595849

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs 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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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