FDA.reportPublic FDA data

ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent

Primary DI
00630414526829
Brand
ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent
Company
Siemens Healthcare Diagnostics Inc.
Model
10335892
Catalog number
5001860
Device description
Triglyceride - ADVIA Chem. - RGT - 4x358/4x362 tests
Published
2020-09-24
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
CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133067000ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.2013-11-22CDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414526829PrimaryGS10
00630414003733Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414526829006304145268296304145268290630414526829
00630414003733006304140037336304140037330630414003733

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of triglycerides in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
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
4
Lot or batch
true
Expiration date on label
true

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