FUJIREBIO DIAGNOSTICS, INC.

FDA-Registered Company Profile for FUJIREBIO DIAGNOSTICS, INC.

FDA-Supplied Establishment Information:

Establishment Registration Number:

2521625

Company Name:

FUJIREBIO DIAGNOSTICS, INC.

Also Known As:

FUJIREBIO AMERICA, INC.
FUJIREBIO, INC

Address:

201 GREAT VALLEY PKWY.

Address 2:

City:

MALVERN

State

Zip / Postal Code:

19355-1307

County:

CHESTER

Country:

Establishment Operation Code(s):

AA - Initial Distributor
ME - Contract Manufacturer
MM - Manufacturer

Establishment Status Code:

A - Active

Year of Most Recent Initial
or Annual Registration:

2007

FDA-Supplied Owner/Operator Information:

Owner/Operator Number:

8031611

Company Name:

FUJIREBIO DIAGNOSTICS, INC.

Address:

2-62-5, NIHONBASHI HAMACHO

Address 2:

CHUO-KU

City:

TOKYO

State:

Zip / Postal Code:

103

Country:

Owner/Operator Phone:

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MR. PETER MINETTI

Company Name:

FUJIREBIO DIAGNOSTICS, INC.

Address:

201 GREAT VALLEY PKWY.

Address 2:

City:

MALVERN

State:

Zip / Postal Code:

19355 1307

Country:

Official Corespondent Phone Number:

610-240-3829

Other Establishment Information:

Establishment Phone:

Fax:

General Email:

somers@centocor.com

Web Site:

http://www.fujirebio.com

Company Brochure:

Keywords:

Company Description:

Services Offered:

About Us:

Differentiation:

FDA-Registered Products Offered by FUJIREBIO DIAGNOSTICS, INC.
	Common Device Name	Proprietary Device Name
1	BNP TEST SYSTEM	ABBOTT ARCHITECT B-TYPE NATRIURETIC PEPTIDE
2	BNP TEST SYSTEM	ABBOTT ARCHITECT B-TYPE NATRIUETIC PEPTIDE (BNP)
3	BNP TEST SYSTEM	ABBOTT ARCHITECT B-TYPE NATRIURETIC PEPTIDE (BNP)
4	CANCER MONITORING TEST SYSTEM, SOLUBLE MESOTHELIN-RELATED	MESOMARK
5	CENTOCOR CA 15-3 RIA	CENTOCOR CA 15-3 RIA
6	CORTISOL TEST SYSTEM	AXSYM CORTISOL
7	DUAL LATEX TEST FOR THE DIFFERENTIAL DETECTION OF TRICHOMONAS AND/OR CANDIDA ANT	SUPER DUO, VAGITEST, AND TRICHOMATE SUPER
8	DUAL LATEX TEST FOR THE DIFFERENTIAL DETECTION OF TRICHOMONAS AND/OR CANDIDA ANT	SUPER DUO, VAGITEST, AND CANDIDATE SUPER
9	FOR THE DETECTION OF ROTAVIRUS IN STOOL OR FAECAL SPECIMENS	ROTASCREEN EIA AND ROTASCREEN
10	FOR THE IN-VITRO DETECTION OF RABIES IN BRAINS AND SUBMAXILLARY GLANDS	CENTOCOR FITC ANTI-RABIES MONOCLONAL GLOBULIN
11	FOR THE MEASURMENT OF CANCER ANTIGEN 125 (CA 125) IN SERUM	CENTOCOR CA 125 RIA
12	IMMUNOLOGICAL TEST FOR 1116N519-9 ANTIBODY DEFINED ANTIGEN (CA19-9)	FUJIREBIO DIAGNOSTICS CA 19-9 RIA
13	OLYMPUS PK CMV-PA TEST SYSTEM & CONTROLS	OLYMPUS PK CMV-PA TEST SYSTEM
14	PK-TP CONTROL SET	OLYMPUS PK TP CONTROL SET
15	TRACROLIMUS TEST SYSTEM	ARCHITECT TRACROLIMUS ASSAY
All FDA-Registered products for this company are displayed above.

Other Products Offered by FUJIREBIO DIAGNOSTICS, INC.:

No products have been listed by this company.

Services Offered by the FUJIREBIO DIAGNOSTICS, INC.:
No services have been listed by this company.

Additional Contact Information for FUJIREBIO DIAGNOSTICS, INC.:
There is no additional contact information for this company.

Companies Related to FUJIREBIO DIAGNOSTICS, INC.

Our records indicate that the following companies are related by ownership.

	Company Name	Address	City	State	Zip	Country
1	FUJIREBIO DIAGNOSTICS, INC.	51 KOMIYA-CHO HACHIOJI-SHI	TOKYO 192			JA

FDA-Registered Company Profile for FUJIREBIO DIAGNOSTICS, INC.

FDA-Registered Products Offered by FUJIREBIO DIAGNOSTICS, INC.

Other Products Offered by FUJIREBIO DIAGNOSTICS, INC.:

Services Offered by the FUJIREBIO DIAGNOSTICS, INC.:

Additional Contact Information for FUJIREBIO DIAGNOSTICS, INC.:

Companies Related to FUJIREBIO DIAGNOSTICS, INC.