Access Ferritin C22490

GUDID 15099590772840

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

Beckman Coulter, Inc.

Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA) Ferritin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15099590772840
NIH Device Record Key3cc6b2e3-96cc-4662-88f7-79289fde4af4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Ferritin
Version Model NumberC22490
Catalog NumberC22490
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590772840 [Primary]

FDA Product Code

JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-15
Device Publish Date2024-04-05

On-Brand Devices [Access Ferritin]

15099590575052The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quant
15099590772840The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quant

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.