APC Setup Kit 737663

GUDID 15099590391508

APC (675/633) Setup Kit

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent
Primary Device ID15099590391508
NIH Device Record Key0a51f674-4de4-47f9-8c60-d1eb7cf14cb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPC Setup Kit
Version Model Number737663
Catalog Number737663
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS115099590391508 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

Devices Manufactured by Beckman Coulter, Inc.

15099590806255 - ACCESS HBsAg2026-01-26 The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepati
15099590806262 - ACCESS HBsAg Confirmatory2026-01-26 The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confir
15099590806279 - Access HBsAg CALIBRATOR2026-01-26 The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qual
15099590806286 - ACCESS HBsAg QC2026-01-26 The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The
15099590806415 - ACCESS anti-HAV2026-01-26 The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of tot
15099590806422 - ACCESS anti-HAV CALIBRATOR2026-01-26 The Access anti-HAV Calibrator is intended to calibrate the Access anti-HAV assay for the in vitro qualitative detection of anti
15099590806439 - ACCESS anti-HAV QC2026-01-26 The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for
15099590799717 - MicroScan2025-12-25 MicroScan LabPro V5.03 System (US), Electronic

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.