DV/DM COV2G/CV2G POS/NEG CTRL KC873

GUDID 00630414298405

DV/DM COV2G/CV2G POS/NEG CTRL

Siemens Healthcare Diagnostics Inc.

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Primary Device ID00630414298405
NIH Device Record Keye5fe7f12-790f-4a78-ab26-8e6a357e1079
Commercial Distribution StatusIn Commercial Distribution
Brand NameDV/DM COV2G/CV2G POS/NEG CTRL
Version Model Number11417773
Catalog NumberKC873
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count6
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

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414298405 [Unit of Use]
GS100630414607054 [Primary]

FDA Product Code

QCHAssayed quality control material for clinical microbiology assays

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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