Atellica IM VitD 11201773

GUDID 00630414234489

Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T

Siemens Healthcare Diagnostics Inc.

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414234489
NIH Device Record Key36a26768-5e25-42d5-b613-22de6b8609c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica IM VitD
Version Model Number11201773
Catalog Number11201773
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
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 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(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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright, Protect from Light

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414234489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRGSYSTEM, TEST, VITAMIN D

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-09
Device Publish Date2018-09-29

On-Brand Devices [Atellica IM VitD]

00630414234489Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
00630414234472Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
00630414293837Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.