LA Control High OQWD13

GUDID 00630414023519

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays

Siemens Healthcare Diagnostics Products GmbH

Multiple coagulation factor IVD, control
Primary Device ID00630414023519
NIH Device Record Key50fae5e2-e429-424c-bab5-9d12b62df973
Commercial Distribution StatusIn Commercial Distribution
Brand NameLA Control High
Version Model Number10873570
Catalog NumberOQWD13
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
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)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414023519 [Primary]
GS100842768019685 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGCCONTROL, PLASMA, ABNORMAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-15

On-Brand Devices [LA Control High]

00630414023519LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test a
00842768008351LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test a
00842768019685LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test a

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