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18,018 catalysts · 4,728 grant · 3,350 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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18,018 catalysts · 4,728 grant · 3,350 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
FD grant. $180,000. PI: Erik Pearson
FD grant. $615,000. PI: Maria Lucia Ishida
FD grant. $31,722. PI: YAN ZHANG
FD grant. $150,000. PI: Chadwick S Linton
FD grant. $300,000. PI: William Gamble
AG grant. $215,998. PI: WILLIAM Anthony TRUITT
AA grant. $672,377. PI: Elise M Weerts
AA grant. $593,803. PI: Xun Ai
AA grant. $459,343. PI: Max E Joffe
AA grant. $3,227,517. PI: Hollis C Karoly
AG grant. $385,351. PI: Richard N Jones
FD grant. $110,000. PI: Edward G. Dudley
HL grant. $139,004. PI: James Omondi Ayieko
HL grant. $15,098. PI: James Omondi Ayieko
AG grant. $493,384. PI: Rachel Elise Bennett
AA grant. $297,389. PI: Carol L Cheatham
AG grant. $291,913. PI: JOHN D ELSWORTH
AG grant. $254,896. PI: Thomas Darmody Arnold
HG grant. $306,094. PI: Brian Stanley Egan
AG grant. $306,872. PI: Jonathan Paul Dekar
AA grant. $49,538. PI: Justin James Verlinden
AG grant. $44,418. PI: Alexis Michelle Topete
DA grant. $249,094
AI grant. $293,142. PI: Alan Gordon Sutherland
Sponsor: DR REDDYS. Form: CAPSULE. Route: ORAL
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JSM. Advisory committee: Microbiology. Type: Traditional
Product code: PDU. Advisory committee: Cardiovascular. Type: Traditional
Product code: IZI. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. — Reason: Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results. — Status: Ongoing
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; — Reason: The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples. — Status: Ongoing
AI grant. $2,112,000. PI: Alison Swaims Kohlmeier
HL grant. $49,538. PI: Parker Ruth
GM grant. $86,930. PI: Sukanya Srinivasan
HD grant. $751,405. PI: Renee A. Heffron
AI grant. $49,256. PI: Adithya Cattamanchi
HL grant. $186,065. PI: Debra Denise Dixon
TW grant. $899,426. PI: cameron E gaskill