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63 catalysts · 28 grant · 23 approval · 5 device 510k · 5 device pma · 2 device recall
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63 catalysts · 28 grant · 23 approval · 5 device 510k · 5 device pma · 2 device recall
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Sponsor: P AND L. Form: GUM, CHEWING. Route: BUCCAL
Sponsor: STERANCO HLTHCARE. Form: SUSPENSION. Route: ORAL
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION
Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAND. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Product code: QBC. Advisory committee: Neurology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Supplement type: 30-Day Notice. Product code: PRL. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: OZA. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No — Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. — Status: Ongoing
Campy CVA Medium 100/PK, R01272 — Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. — Status: Ongoing
AI grant. $489,500. PI: Mark P Boldin
AI grant. $524,626. PI: DONNA M NEUMANN
DK grant. $728,742. PI: Qunfeng Dong
DK grant. $773,901. PI: BRYAN R KESTENBAUM
AG grant. $35,593. PI: Yash Pershad
NS grant. $582,252. PI: Aaron D Boes
AI grant. $3,080,416. PI: Patrick Joseph Brennan
AI grant. $470,219. PI: Fabienne Gally
DK grant. $127,500. PI: Wade William Sugden
AI grant. $440,908. PI: Francis Alonzo
AI grant. $191,163. PI: James D Weger
AI grant. $476,436. PI: BENJAMIN JOACHIM SCHMIEDEL
DK grant. $588,892. PI: Adebowale Adebiyi
NS grant. $598,687. PI: Amanda Joy Whipple
AI grant. $451,000. PI: Jingxin Wang