PATHFAST Sample Diluent 2

GUDID 04987595300028

PHC CORPORATION

Buffered sample diluent IVD
Primary Device ID04987595300028
NIH Device Record Key53b149dc-e318-4543-8b7f-d5edd19ac480
Commercial Distribution StatusIn Commercial Distribution
Brand NamePATHFAST Sample Diluent 2
Version Model NumberN/A
Company DUNS716055632
Company NamePHC CORPORATION
Device Count1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987595300028 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-28
Device Publish Date2025-04-18

Devices Manufactured by PHC CORPORATION

04987595300011 - PATHFAST Sample Diluent 12025-04-28
04987595300028 - PATHFAST Sample Diluent 22025-04-28
04987595300028 - PATHFAST Sample Diluent 22025-04-28
04987595301803 - PATHFAST hs-cTnI-II2024-05-09
04987905300540 - PHCbi2020-04-17 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
04987905300533 - PHCbi2019-11-25 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
04987905300120 - Panasonic2019-06-11 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
04987905300144 - Panasonic2019-06-11 This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity
04987905300014 - Panasonic2018-12-21 This equipment is designed for low temperature storage of blood and blood products.

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