ADVIA Centaur aHBe2 QC KIT 10720832

GUDID 00630414167947

Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit

Siemens Healthcare Diagnostics Inc.

Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control Hepatitis B virus e-antigen total antibody IVD, control
Primary Device ID00630414167947
NIH Device Record Key154357ad-e86e-46b7-94f2-8a097243ae48
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA Centaur aHBe2 QC KIT
Version Model Number10720832
Catalog Number10720832
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
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(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

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store upright, protect from light, do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414167947 [Primary]

FDA Product Code

JIXCalibrator, multi-analyte mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-14

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