Alpha2-macroglobulin 09029524190

GUDID 05415168006873

In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.

Diagam

Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry
Primary Device ID05415168006873
NIH Device Record Key349a46f4-4ac9-46e0-84c8-1dba8ceaf106
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlpha2-macroglobulin
Version Model Number09029524190
Catalog Number09029524190
Company DUNS374384030
Company NameDiagam
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105415168006873 [Primary]

FDA Product Code

DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-15
Device Publish Date2021-12-07

On-Brand Devices [Alpha2-macroglobulin]

05415168003476Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on coba
05415168006873In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples

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