IMMULITE® 2000 Systems FT3 Free T3 L2KF36

GUDID 00630414961385

Free T3 - IMMULITE - RGT - 600 Tests

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414961385
NIH Device Record Key96c33265-ea54-4f68-ba8c-4b7dc96d316a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMULITE® 2000 Systems FT3 Free T3
Version Model Number10381682
Catalog NumberL2KF36
Company DUNS296822794
Company NameSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414961385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDPRADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [IMMULITE® 2000 Systems FT3 Free T3]

00630414961385Free T3 - IMMULITE - RGT - 600 Tests
00630414961361Free T3 - IMMULITE - RGT - 200 Tests

Trademark Results [IMMULITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMMULITE
IMMULITE
74098401 1653588 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1990-09-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.