FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge TU

Primary DI
00842768015496
Brand
Dimension Vista® Flex® reagent cartridge TU
Company
Siemens Healthcare Diagnostics Inc.
Model
10445102
Catalog number
K6075
Device description
Thyronine Uptake Flex® reagent cartridge, 160 tests
Published
2016-09-24
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
KHQRADIOASSAY, TRIIODOTHYRONINE UPTAKE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015496PrimaryGS10
00630414004761Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015496008427680154968427680154960842768015496
00630414004761006304140047616304140047610630414004761

GMDN Terms#

Term, Definition table
TermDefinition
Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroxine binding globulin (TBG) 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(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

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

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