FDA.reportPublic FDA data

Dimension Vista® Soluble Transferrin Receptor Flex® reagent cartridge

Primary DI
00842768006241
Brand
Dimension Vista® Soluble Transferrin Receptor Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445909
Catalog number
K7070
Device description
For the quantitative measurement of soluble transferrin receptor in human serum and plasma on the Dimension Vista® System
Published
2016-09-24
Public version status
Update
Distribution status
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
DHRSYSTEM, TEST, RHEUMATOID FACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHRSystem, Test, Rheumatoid FactorImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006241PrimaryGS10
00842768020162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006241008427680062418427680062410842768006241
00842768020162008427680201628427680201620842768020162

GMDN Terms#

Term, Definition table
TermDefinition
Soluble transferrin receptor IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of soluble transferrin receptor 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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
2
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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00630414240336INNOVANCE Apixaban Controls10873674OPPV052024-11-26
00630414240343INNOVANCE Apixaban Standards10873675OPPW052024-11-26
00630414240404INNOVANCE Anti-Xa10873681OPPU052024-11-26
00842768018800BC von Willebrand Reagent10874080108740802024-09-12
00842768019661LA 2 Confirmation Reagent10873902108739022024-03-29
00842768019654LA 1 Screening Reagent10873904108739042024-03-29
00842768019678LA Control Low10873935108739352024-03-29
00842768019685LA Control High10873936108739362024-03-29
00630414640433vWF Ag10873845108738452024-03-29
00630414639352Berichrom Plasminogen10873885108738852024-03-25
00630414639437Berichrom a2-Antiplasmin10873884108738842024-03-25
00630414639444Berichrom Antithrombin III (A)10873898108738982024-03-25
00630414639468INNOVANCE VWF Ac10873906108739062024-03-25
00842768018817Coagulation Factor X Deficient Plasma10873882108738822024-03-25
00842768018879Coagulation Factor XI Deficient Plasma10873883108738832024-03-25
00842768018725Batroxobin Reagent10873889108738892024-03-25
00630414639628Berichrom Protein C10873892108738922024-03-25

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