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9,284 catalysts · 3,153 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
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9,284 catalysts · 3,153 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
AI grant. $670,017. PI: Paula Maria Oliver
AI grant. $436,605. PI: Charles Kyriakos Vorkas
AI grant. $443,850. PI: Kathryn A Knoop
AI grant. $553,779. PI: Nathaniel J Moorman
AI grant. $200,000. PI: CURT M HORVATH
AI grant. $560,455. PI: Lars Dietrich
AI grant. $2,800,280. PI: Mandy J McGeachy
DE grant. $340,149. PI: Gina Lewin
DK grant. $123,750. PI: Jacqueline Anne Seiglie
DK grant. $791,520. PI: Matthew A Burchill
AI grant. $791,990. PI: PATRICK L SINN
AI grant. $462,000. PI: Miguel Fribourg
AI grant. $791,797. PI: Carla Rose Nowosad
AI grant. $427,625. PI: Takeshi Egawa
NS grant. $37,249. PI: Haley Jetter
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