FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge URCA

Primary DI
00842768015519
Brand
Dimension Vista® Flex® reagent cartridge URCA
Company
Siemens Healthcare Diagnostics Inc.
Model
10445145
Catalog number
K1077
Device description
Uric Acid Flex® reagent cartridge, 560 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
KNKAcid, uric, uricase (colorimetric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015519PrimaryGS10
00630414005126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015519008427680155198427680155190842768015519
00630414005126006304140051266304140051260630414005126

GMDN Terms#

Term, Definition table
TermDefinition
Uric acid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of uric acid in a clinical specimen, using an enzyme spectrophotometry 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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654133Atellica CH UASiemens Healthcare Diagnostics Inc.KNK2026-04-08
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08806141304036ONE+Step Uric AcidDFI CO.,LTDKNK2025-09-03
08806141304029ONE+Step Uric AcidDFI CO.,LTDKNK2025-08-22
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10673486002263Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-30
10673486002300Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002317Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002324Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002331Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSKNK2023-11-15
10673486002348Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002355Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSKNK2023-11-15
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