FDA.reportPublic FDA data

Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH

Primary DI
00842768013805
Brand
Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH
Company
Siemens Healthcare Diagnostics Inc.
Model
10444911
Catalog number
RF412
Device description
Thyroid Stimulating Hormone Flex® reagent cartridge, 200 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
CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE
JLWRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEWRadioimmunoassay, Parathyroid HormoneClinical Chemistry2
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112999000DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics2011-11-22JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013805PrimaryGS10
00630414003986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013805008427680138058427680138050842768013805
00630414003986006304140039866304140039860630414003986

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) 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
4
Lot or batch
true
Expiration date on label
true

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