FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge TU

Primary DI
00842768005695
Brand
Dimension® Flex® reagent cartridge TU
Company
Siemens Healthcare Diagnostics Inc.
Model
10444912
Catalog number
DF75A
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
CIGDIAZO COLORIMETRY, BILIRUBIN
KHQRADIOASSAY, TRIIODOTHYRONINE UPTAKE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2
KHQRadioassay, Triiodothyronine UptakeClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862359000METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEME.I. Dupont DE Nemours & Co., Inc.1986-08-19CIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005695PrimaryGS10
00630414003993Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005695008427680056958427680056950842768005695
00630414003993006304140039936304140039930630414003993

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
8
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414614922Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
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00852169008317ClearChem Diagnostics Inc. Total BilirubinCLEARCHEM DIAGNOSTICS INC.CIG2023-01-20
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