IMMULITE® 2000 Systems aBs Anti-HBs L2KAB2(D)

GUDID 00630414982182

aBs Anti-HBs Kit 200 Test

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414982182
NIH Device Record Key2c8a8e27-33ac-45b6-bc85-440c01428a71
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMULITE® 2000 Systems aBs Anti-HBs
Version Model Number10483780
Catalog NumberL2KAB2(D)
Company DUNS296822794
Company NameSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Usetrue
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
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Phone+1(877)229-3711
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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
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

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

Device Issuing AgencyDevice ID
GS100630414982182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-05
Device Publish Date2014-09-24

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00630414006246 - IMMULITE 2000 rMal d 1 Specific Allergen2022-09-20 rMal d 1 Allergen
00630414006253 - IMMULITE 2000 rPru av 3 Specific Allergen2022-09-20 rPru av 3 Allergen

Trademark Results [IMMULITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMMULITE
IMMULITE
74098401 1653588 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1990-09-19

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