Access Intact PTH A16972

GUDID 15099590201937

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay fir the quantitative determination of intact parathyroid hormone (parathyin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590201937
NIH Device Record Keycd99d00f-8565-4c2e-a903-520a2ac59174
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Intact PTH
Version Model NumberA16972
Catalog NumberA16972
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
GS115099590201937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEWRadioimmunoassay, Parathyroid Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-09-09

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