|
FDA-Registered Company Profile for MP BIOMEDICALS DIAGNOSTICS DIVISION
|
| FDA-Supplied Establishment Information: |
|
| Establishment Registration Number: |
2419955 |
| Company Name: |
MP BIOMEDICALS DIAGNOSTICS DIVISION |
| Also Known As: |
ICN EAST, INC.
MP BIOMEDICALS, INC.
MP BIOMEDICALS EAST, INC.
|
| Address: |
29525 FOUNTAIN PARKWAY |
| Address 2: |
|
| City: |
SOLON |
| State |
OH |
| Zip / Postal Code: |
44139 |
| County: |
CUYAHOGA |
| Country: |
US |
| Establishment Operation Code(s): |
MM - Manufacturer
MR - Remanufacturer
RR - Repackager/Relabeller
|
| Establishment Status Code: |
A -
Active
|
Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9057708 |
| Company Name: |
MP BIOMEDICALS, LLC
|
| Address: |
15 MORGAN |
| Address 2: |
|
| City: |
IRVINE |
| State: |
CA |
| Zip / Postal Code: |
92618 |
| Country: |
US |
| Owner/Operator Phone: |
949-833-2500
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MR. WILLIAM RICHARDSON |
| Company Name: |
MP BIOMEDICALS DIAGNOSTICS DIVISION |
| Address: |
29525 FOUNTAIN PARKWAY |
| Address 2: |
|
| City: |
SOLON |
| State: |
OH |
| Zip / Postal Code: |
44139 |
| Country: |
US |
| Official Corespondent Phone Number: |
440-337-1200 285
|
 |
 |
| Other Establishment Information: |
| Establishment Phone: |
|
| Fax: |
|
| General Email: |
|
| Web Site: |
|
| Company Brochure: |
|
| Keywords: |
|
| Company Description: |
|
| Services Offered: |
|
| About Us: |
|
| Differentiation: |
|
FDA-Registered Products Offered by MP BIOMEDICALS DIAGNOSTICS DIVISION
|
|
Common Device Name |
Proprietary Device Name |
| 1 |
(SPAG) MODEL SPAG-2 GOOD SERIES VIRATEK, INC. |
NEBULIZER (DIRECT PATIENT INTERFACE) |
| 2 |
ANCA, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES |
MOP ELISA, PR3 ELISA |
| 3 |
B-HCG 125 I RADIOIMMUNOASSAY KIT |
B-HCG 125 I RADIOIMMUNOASSAY KIT |
| 4 |
CALCITONIN |
ULTRA-SENSITIVE CALCITONIN DOUBLE ANTIBODY |
| 5 |
CONJUGATED BILE ACIDS SOLID PHASE RADIOIMMUNOASSAY KIT 125 I |
CONJUGATED BILE ACIDS SOLID PHASE RADIOIMMUNOASSAY KIT 125 I |
| 6 |
DIGOXIN RADIOIMMUNOASSAY SYSTEM 125 I |
DIGOXIN,SOLID PHASE RADIOIMMUNOASSAY 125 I SINGLE LOT COMPONENT SYSTEM |
| 7 |
DOUBLE ANTIBODY KIT/COATED TUBE KIT |
MULTIPLE PRODUCT NAMES |
| 8 |
E2 |
IMMUCHEM 17B-ESTRADIOL DOUBLE ANTIBODY, IMMUCHEM 17B-ESTRADIOL COATED TUBE |
| 9 |
ESTRADIOL-17B & ESTRONE 1125 |
IMMUCHEM TOTAL ESTROGENS (E1 & E2) DOUBLE ANTIBODY |
| 10 |
ESTRIOL ELISA |
ESTRIOL ELISA |
| 11 |
FERRITIN 125 I RADIOIMMUNOASSAY KIT |
FERRITIN 125 I RADIOIMMUNOASSAY KIT |
| 12 |
FOLATE RADIOIMMUNOASSAY KIT 125 I |
FOLATE RADIOIMMUNOASSAY KIT 125 I |
| 13 |
FSH ELISA, PROCEDURE FOR THE RIA OF HUMAN SERUM FOLLICLE STIMULATING HORMONE |
MULTIPLE PRODUCT NAMES |
| 14 |
GALACTOSE ENZYME ASSAY |
IMMUCHEM GAL-MW EA |
| 15 |
GASTRIN |
GASTRIN EIA KIT |
| 16 |
HOMOGENIZER, GRINDER |
FASTPREP 24 |
| 17 |
HSV |
MULTIPLE HERPES SIMPLEX KITS |
| 18 |
IMMUCHEM ALDOSTERONE DOUBLE ANTIBODY |
IMMUCHEM ALDOSTERONE DOUBLE ANTIBODY |
| 19 |
IMMUCHEM DHEA-SULFATE DOUBLE ANTIBODY, IMMUCHEM DHEA-SULFATE ANTIBODY COATED TUB |
IMMUCHEM DHEA-SULFATE DOUBLE ANTIBODY, IMMUCHEM DHEA-SULFATE ANTIBODY COATED TUB |
| 20 |
IMMUNCHEM CORTISOL COATED TUBE |
IMMUNCHEM CORTISOL COATED TUBE |
| 21 |
INFANT OXYGEN HOOD |
AEROSOL DELIVERY HOOD VIRATEK, INC. |
| 22 |
MITOCHONDRIA ELISA |
MITOCHONDRIA ELISA |
| 23 |
MONOCLONAL ANTIBODY |
CD4 FITC |
| 24 |
PHENYLALANINE ASSAY |
IMMUCHEM PHE-MW EA |
| 25 |
PROCEDURE FOR THE RIA OF ADRENOCORTICOTROPIC HORMONE |
IMMUCHEM ACTH DOUBLE ANTIBODY |
| 26 |
PROCEDURE FOR THE RIA OF DIGOXIN |
AUTOPAK DIGOXIN ANTIBODY COATED TUBE, IMMUCHEM DIGOXIN ANTIBODY COATED TUBE |
| 27 |
PROCEDURE FOR THE RIA OF HUMAN PLASMA GLUCAGON |
IMMUCHEM GLUCAGON DOUBLE ANTIBODY |
| 28 |
PROCEDURE FOR THE RIA OF HUMAN SERUM GROWTH HORMONE |
IMMUCHEM HGH DOUBLE ANTIBODY |
| 29 |
PROCEDURE FOR THE RIA OF HUMAN SERUM INSULIN |
MULTIPLE PRODUCT NAMES |
| 30 |
PROCEDURE FOR THE RIA OF HUMAN SERUM LUTENIZING HORMONE |
MULTIPLE PRODUCT NAMES |
| 31 |
PROCEDURE FOR THE RIA OF HUMAN SERUM PROLACTIN |
MULTIPLE PRODUCT NAMES |
| 32 |
PROGESTERONE |
MULTIPLE PRODUCT NAMES |
| 33 |
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY KIT (125I) |
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY KIT (125I) |
| 34 |
PTH INTACT RADIOIMMUNOASSAY COATED TUBE |
PTH INTACT RADIOIMMUNOASSAY COATED TUBE |
| 35 |
QCA BLOOD CHEMISTRY ANALYZER |
QCA BLOOD CHEMISTRY ANALYZER |
| 36 |
QUALITROL DHP IMMUNDASSAY CONTROL LEVELS, 1, 2 & 3 |
MULTI |
| 37 |
REAGENTS,SPECIFIC,ANALYTE |
REAGENTS,SPECIFIC,ANALYTE |
| 38 |
RHEUMATOID FACTOR ELISA |
RHEUMATOID FACTOR ELISA |
| 39 |
RIBOSOMAL P ELISA |
RIBOSOMAL P ELISA |
| 40 |
RUBEOLA, MEASLES |
MULTIPLE MEASLES ELISA KITS |
| 41 |
SHBG, SEX STEROID BINDING PROTEIN, SBP |
SEX HORMONE BINDING PROTEIN COATED TUBE IRMA |
| 42 |
SIMULTANEOUS RADIOASSAY FOR VITAMIN B12 AND FOLIC ACID |
SIMULTRAC RADIOASSAY KIT-VITAMIN 57CO/FOLATE 125I |
| 43 |
SIMULTRAC FREE T4 57 CO/TSH 125 I RADIOIMMUNOASSAY KIT |
SIMULTRAC FREE T4 57 CO/TSH 125 I RADIOIMMUNOASSAY KIT |
| 44 |
T 3 SOLID PHASE RADIOIMMUNOASSAY KIT |
T 3 SOLID PHASE RADIOIMMUNOASSAY KIT |
| 45 |
T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I |
T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I |
| 46 |
T. GONDII |
MULTIPLE TOXOPLASMA GONDII KITS |
| 47 |
T3 UPTAKE SOLID PHASE RADIOASSAY SINGLE LOT COMPONENT SYSTEM |
T3 UPTAKE SOLID PHASE RADIOASSAY SINGLE LOT COMPONENT SYSTEM |
| 48 |
THYROGLOBULIN ELISA |
THYROGLOBULIN ELISA |
| 49 |
TISSUE GRINDING MATRIX TUBE |
FASTPREP LYSING MATRIX TUBE |
| 50 |
TSH ELISA OR EIA, NEONATAL TSH ELISA |
IMMUCHEM TSH-MW ELISA, IMMUCHEM NEONATAL TSH-MP ELISA |
| 51 |
VARIOUS METHOD, IMMUNODIFFUSION, IMMUNOGLOBULINS (G, A, M) PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 52 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER PRODUCTS |
MULTIPLE VARICELLS-ZOSTER KITS |
| 53 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS PRODUCTS |
MULTIPLE CYTOMEGALOVIRUS KITS |
| 54 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP) PRODUCTS |
MULTIPLE CHLAMYDIA KITS |
| 55 |
VARIOUS ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL PRODUCTS |
DSDNA ELISA |
| 56 |
VARIOUS WHOLE HUMAN SERUM, ANTIGEN, ANTISERUM, CONTROL PRODUCTS |
QUALITROLIGAME CONTROLS, LEVELS 1 & 2 |
| 57 |
VARIOUS RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE PRODUCTS |
NEOSCREEN ELISA HYDROXY PROGESTERONE |
| 58 |
VARIOUS SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL PRODUCTS |
MULTIPLE CARDIOLIPIN ELISA KITS |
| 59 |
VARIOUS RUBELLA KITS |
MULTIPLE RUBELLA KITS |
| All FDA-Registered products for this company are displayed above. |