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18,415 catalysts · 4,728 grant · 3,407 8k filing · 2,627 approval · 2,156 device 510k · 1,745 device recall · 1,501 device pma
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18,415 catalysts · 4,728 grant · 3,407 8k filing · 2,627 approval · 2,156 device 510k · 1,745 device recall · 1,501 device pma
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
AT grant. $1,256,373. PI: Margaret Bublitz
TW grant. $28,620. PI: James Samwel Ngocho
DE grant. $754,426. PI: DAVID A KEITH
AG grant. $326,382. PI: Risa Stein
CA grant. $1,313,567. PI: ARTHUR P BERTOLINO
AG grant. $475,014. PI: Samuel Newton Sathyanesan
AG grant. $1,353,901. PI: TAMARA DAWN AFIFI
MH grant. $2,908,921. PI: Pierre F Apostolides
TW grant. $670,856. PI: Alissa Davis
MH grant. $242,827. PI: Jenny Leigh Newlon