Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device kit, quality control for blood banking reagents
Regulation Description Quality control kit for blood banking reagents.
Product CodeKSF
Regulation Number 864.9650
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAGAST
  SUBSTANTIALLY EQUIVALENT 1
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILLIPORE (UK) LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 2 2
False Negative Result 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Unspecified Eye / Vision Problem 1 1
Fever 1 1
No Consequences Or Impact To Patient 1 1

-
-