FUJIREBIO DIAGNOSTICS, INC.

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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.

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.:

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