Atellica IM Tup

Primary DI
00630414600246
Brand
Atellica IM Tup
Company
Siemens Healthcare Diagnostics Inc.
Model
10995711
Catalog number
10995711
Device description
T Uptake (Tup) Atellica IM - RGT 250T
Published
2018-02-06
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970539000CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.1997-03-24KHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600246PrimaryGS10
00630414007885Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600246006304146002466304146002460630414600246
00630414007885006304140078856304140078850630414007885

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid uptake (T-uptake) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative determination of thyroid hormone uptake (T-uptake), or the unbound/free portion of thyroxine binding globulin (TBG) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

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