Dimension EXL LOCI Troponin I High Sensitive RF627

GUDID 00842768037726

LOCI High-Sensitivity Troponin I (TNIH)

Siemens Healthcare Diagnostics Inc.

Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay Troponin I IVD, kit, chemiluminescent immunoassay
Primary Device ID00842768037726
NIH Device Record Key6a05a265-fad9-4a72-9715-9ab4b6ac7cc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDimension EXL LOCI Troponin I High Sensitive
Version Model Number10471068
Catalog NumberRF627
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailXX@XX.XX
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
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
GS100630414225203 [Unit of Use]
GS100842768037726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-24
Device Publish Date2019-10-16

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414624488 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
00630414624501 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
00630414624518 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT 110T
00630414624525 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM – RGT 550T
00630414624532 - Atellica IM TSH3ULII MCM set2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
00630414624693 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
00630414624709 - ADVIA Centaur TSH3ULII MCM SET2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set
00630414317434 - Clinistix Kidney Health Test System2024-05-13 Test Strips for the Determination of Albumin and Creatinine in Urine
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.