Access Intact PTH Calibrators A16953

GUDID 15099590201920

The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Primary Device ID15099590201920
NIH Device Record Keyf79b2ecc-5b29-4b51-ae6f-5e6bf2c8b8e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Intact PTH Calibrators
Version Model NumberA16953
Catalog NumberA16953
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
GS115099590201920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCalibrator, Secondary

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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