Atellica IM VitD 11206265

GUDID 00630414293837

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 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 ID00630414293837
NIH Device Record Key12c8fa2d-8b3e-4f5f-b378-f46b94b1494f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica IM VitD
Version Model Number11206265
Catalog Number11206265
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
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
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
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
GS100630414293837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCalibrator, primary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

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.