FDA.reportPublic FDA data

ADVIA® Chemistry TRIG_c Reagent

Primary DI
00630414590394
Brand
ADVIA® Chemistry TRIG_c Reagent
Company
Siemens Healthcare Diagnostics Inc.
Model
10697575
Catalog number
10697575
Device description
Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00630414590394PrimaryGS10
00630414005966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414590394006304145903946304145903940630414590394
00630414005966006304140059666304140059660630414005966

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
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