Mp Biomedicals Diagnostics Division

FDA Filings

This page includes the latest FDA filings for Mp Biomedicals Diagnostics Division. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2419955
• FEI Number: 2419955
• Name: MP BIOMEDICALS DIAGNOSTICS DIVISION
• Owner & Operator: MP BIOMEDICALS, LLC
• Contact Address: 29525 FOUNTAIN PARKWAY ; Solon OH 44139 US
• Official Correspondent:
  • Steven Scaggs
  • 1-440-3371200-7755
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 29525 Fountain Pkwy ; Solon, OH 44139 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
JNO MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Blood Spot Trypsin MW ELISA	2015-12-07
PMN K940233 | JLX MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	17OH-Progesterone, Neonatal EIA	2015-02-12
PMN K913963 | JLW MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Immuchem TSH-MW ELISA	2015-02-11
PMN K951329 | JIA MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem Galactose MW EIA	2010-12-17
PMN K885198 | JLX MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Neonatal 17OH-Progesterone CT	2010-12-17
PMN K883726 | JLW MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Neonatal TSH CT	2010-12-17
PMN K871008 | CDX MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Neonatal T4 CT	2010-12-17
PMN K865071 | JLW MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	TSH CT	2010-12-17
PMN K854094 | JLS MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	17OH-Progesterone CT	2010-12-17
PMN K842365 | CGR MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Corticote	2010-12-17
PMN K840959 | CDP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Free T3 RIA	2010-12-17
PMN K840886 | JLS MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	17OH-Progesterone DA	2010-12-17
PMN K823264 | CEC MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Free T4 Solid Phase RIA	2010-12-17
PMN K813484 | JLS MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Progesterone CT	2010-12-17
PMN K800126 | JLS MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Progesterone DA	2010-12-17
PMN K791999 | CDZ MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Testosterone DA	2010-12-17
PMN K791740 | JKB MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem 11-Desoxycortisol DA	2010-12-17
PMN K791652 | CHP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Estradiol DA	2010-12-17
PMN K822721 | CDD MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	SimulTRAC SNB B12 Folate	2008-02-06
PMN K926106 | JNB MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Immuchem PHE-MW EIA	2007-12-01
PMN K904816 | CDX MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	T4 Solid Phase Radioimmunoassay	2007-12-01
PMN K862204 | CJM MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Immuchem Aldosterone Double Ab	2007-12-01
PMN K831855 | CKG MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Immuchem ACTH Double Antibody	2007-12-01
PMN K822728 | CGN MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	SimulTRAC S Radioimmunoassay	2007-12-01
PMN K811536 | CDZ MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Sex Hormone Binding Protein CT	2007-12-01
PMN K791835 | CGR MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Immuchem Cortisol Coated Tube	2007-12-01
PMN K781337 | KWW MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Conjugated Bile Acids Solid Phase	2007-12-01
PMN K771638 | DPO MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Digoxin, Solid Phase Radioimmunoass	2007-12-01
MVU MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	SPECIFIC	2003-04-29
MVU MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	REAGENTS	2003-04-29
MVU MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ANALYTE	2003-04-29
JME MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM GLUCAGON DOUBLE ANTIBODY	1996-09-18
JLX MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	NEOSCREEN ELISA HY	1996-09-18
CFP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem Insulin CT	1996-09-18
CFL MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM HGH DOUBLE ANTIBODY	1996-09-18
JMD MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM TOTAL ESTROGENS (E1	1996-07-31
JMD MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	E2) DOUBLE ANTIBODY	1996-07-31
JKC MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM DHEA-SULFATE DOUBLE ANTIBO	1996-07-31
JKC MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM DHEA-SULFATE ANTIBODY COA	1996-07-31
JKC MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ATED TUB	1996-07-31
CIZ MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem Androstenedione DA	1996-07-31
CHP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM 17B-ESTRADIOL DOUBLE ANTIB	1996-07-31
CHP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	IMMUCHEM 17B-ESTRADIOL COATED TUBE	1996-07-31
CHP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	BE	1996-07-31
KHQ MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	T3 UPTAKE SOLID PHASE RADIOASS	1995-06-01
CGC MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	Gastrin RIA kit	1995-05-30
JLS MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem Progesterone RIA	1985-01-16
CFT MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	ImmuChem Prolactin CT	1982-12-15
CDP MP BIOMEDICALS DIAGNOSTICS DIVISION [MP BIOMEDICALS, LLC]	T 3 SOLID PHASE RA	1980-06-30