Dimension® Flex® reagent cartridge IGA DF74

GUDID 00842768005688

Immunoglobulin A Flex® reagent cartridge, 120 tests

Siemens Healthcare Diagnostics Inc.

Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
Primary Device ID00842768005688
NIH Device Record Keye2584dae-6126-4053-aa2d-d64ea91c9540
Commercial Distribution StatusIn Commercial Distribution
Brand NameDimension® Flex® reagent cartridge IGA
Version Model Number10444982
Catalog NumberDF74
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count4
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)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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414004587 [Unit of Use]
GS100842768005688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFQRADIOIMMUNOASSAY, IMMUNOGLOBULINS (G, A, M)

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 Date2016-09-24

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Trademark Results [Dimension]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIMENSION
DIMENSION
98746674 not registered Live/Pending
Guangzhou Yuanjie Electronic Technology Co., Ltd.
2024-09-12
DIMENSION
DIMENSION
98597698 not registered Live/Pending
Scientific Games, LLC
2024-06-12
DIMENSION
DIMENSION
98508890 not registered Live/Pending
HORIZON MEDIA LLC
2024-04-19
DIMENSION
DIMENSION
98038278 not registered Live/Pending
Liuzhou Gaofei Technology Co., Ltd.
2023-06-12
DIMENSION
DIMENSION
97774387 not registered Live/Pending
Farmers Feed Mill, Inc.
2023-01-31
DIMENSION
DIMENSION
97744161 not registered Live/Pending
SATCO Products, Inc.
2023-01-06
DIMENSION
DIMENSION
97638085 not registered Live/Pending
Dimension Management, L.P.
2022-10-19
DIMENSION
DIMENSION
97501679 not registered Live/Pending
Danqi Shen
2022-07-13
DIMENSION
DIMENSION
97078680 not registered Live/Pending
American Pacific Industries, Inc.
2021-10-18
DIMENSION
DIMENSION
90657575 not registered Live/Pending
Ruggable LLC
2021-04-20
DIMENSION
DIMENSION
90546735 not registered Live/Pending
Unique Sales and Marketing
2021-02-25
DIMENSION
DIMENSION
88897959 not registered Live/Pending
Grail, Inc.
2020-05-01

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