IMMULITE® 2000 Systems AF AFP L2KAP6

GUDID 00630414961040

AF AFP Kit 600 Test

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414961040
NIH Device Record Keydabb61bc-5e4f-4583-9daa-0bc5b3973cb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMMULITE® 2000 Systems AF AFP
Version Model Number10381184
Catalog NumberL2KAP6
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
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 *Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Light
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Light
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
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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414961040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

On-Brand Devices [IMMULITE® 2000 Systems AF AFP]

00630414961040AF AFP Kit 600 Test
00630414961033AF AFP Kit 200 Test

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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