DV/DM COV2G/CV2G CAL KC872

GUDID 00630414298399

DV/DM COV2G/CV2G CAL

Siemens Healthcare Diagnostics Inc.

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Primary Device ID00630414298399
NIH Device Record Keyd9dd5144-49e8-4e51-8b36-34d6c7c4a241
Commercial Distribution StatusIn Commercial Distribution
Brand NameDV/DM COV2G/CV2G CAL
Version Model Number11417772
Catalog NumberKC872
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count2
DM Exemptfalse
Pre-market Exempttrue
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
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
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
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright
Handling Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Upright

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414298399 [Unit of Use]
GS100630414607047 [Primary]

FDA Product Code

JITCalibrator, secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-22

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