BIOKIT S.A. - LLISSA D'AMUNT, BARCELONA,

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FDA-Registered Company Profile for BIOKIT S.A.

FDA-Supplied Establishment Information:

Establishment Registration Number:

9610746

Company Name:

BIOKIT S.A.

Address:

CAN MALE, S/N (Map)

Address 2:

City:

LLISSA D'AMUNT, BARCELONA

State

Zip / Postal Code:

08186

County:

Country:

Establishment Operation Code(s):

MM - Manufacturer
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:

8030752

Company Name:

BIOKIT S.A.

Address:

CAN MALE, S/N

Address 2:

City:

LLISSA D'AMUNT, BARCELONA

State:

Zip / Postal Code:

08186

Country:

Owner/Operator Phone:

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MR. JUAN GUIXER

Company Name:

BIOKIT S.A.

Address:

CAN MALE, S/N

Address 2:

City:

LLISSA D'AMUNT, BARCELONA

State:

Zip / Postal Code:

08186

Country:

Official Corespondent Phone Number:

349-386-09000

FDA-Supplied US Agent Information:

US Agent Contact Name / Title:

MS. CAROL MARBLE , REGULATORY AFFAIRS MANAGER

Company Name:

INSTRUMENTATION LABORATORY CO.

Address:

113 HARTWELL AVE.

Address 2:

City:

LEXINGTON

State:

Zip Code:

02421

Country:

US Agent Phone Number:

781-861-4467

US Agent Email Address:

cmarble@qa.ilww.com

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 BIOKIT S.A.
	Common Device Name	Proprietary Device Name
1	A1- AGP TURBIDIMETRY TEST	MULTIPLE (QUANTIA A1 AG)
2	A1-AT TURBIDIMETRY TEST	MULTIPLE (QUANTIA A1-AT)
3	BETA-2-MICROGLOBULIN LATEX AGGLUTINATION TEST	MULTIPLE (QUANTIA BETA-2 MICROGLOBULIN)
4	CHEMILUMINESCENT PTH REAGENT	ARCHITECT INTACT PTH
5	CHEMILUMINESCENT SHBG TEST	ARCHITECT SHBG
6	CHEMILUMINESCENT THEOPHYLLINE CALIBRATORS	ARCHITECT ITHEOPHYLLINE CALIBRATORS
7	CHEMILUMINESCENT THEOPHYLLINE REAGENT	ARCHITECT ITHEOPHYLLINE REAGENTS
8	CHEMILUMINISCENT DHEA-S TEST	ARCHITECT DHEA-S
9	C-REACTIVE PROTEIN LATEX AGGLUTINATION TESTS	MULTIPLE PRODUCT NAMES
10	CRP LATEX AGGLUTINATION TEST	MULTIPLE PRODUCT NAMES
11	D-DIMER CONTROLS	MULTIPLE PRODUCT NAMES
12	D-DIMER LATEX AGGLUTINATION TEST	MULTIPLE PRODUCT NAMES
13	FACTOR XIII LATEX AGGLUTINATION TEST	HEMOSIL FACTOR XIII ANTIGEN
14	FERRITIN LATEX AGGLUTINATION TEST	MULTIPLE (QUANTIA FERRITIN)
15	I.M. LATEX AGGLUTINATION TEST	MULTIPLE (MONOGEN)
16	IGE LATEX AGGLUTINATION TEST	MULTIPLE (QUANTIA IGE)
17	LP(A) LATEX AGGLUTINATION TEST	MULTIPLE (QUANTIA LP(A))
18	MYOGLOBIN LATEX AGGLUTINATION TEST	MULTIPLE (QUANTIA MYOGLOBIN)
19	PROTEINS CALIBRATOR	MULTIPLE (QUANTIA LP(A) STANDARD)
20	PROTEINS CALIBRATOR	MUTIPLE (QUANTIA FERRITIN STANDARD)
21	PROTEINS CONTROL	MULTIPLE (QUANTIA FERRITIN/MYOGLOBIN/IGE CONTROL)
22	RAPID PLASMA REAGIN TEST KIT	BIOKIT S.D.
23	RF LATEX AGGLUTINATION TEST	NO PROPRIETARY NAME LISTED
24	RHEUMA TEST CONTROLS	MULTIPLE (QUANTEX ASO-CRP-RF CONTROL)
25	RUBELLA LATEX AGGLUTINATION TEST	MULTIPLE (RUBAGEN)
26	SLO LATEX AGGLUTINATION TEST	BIOKIT S.A.
27	TURBIDMETRIC HOMOCYSTEINE ASSAY	HEMOSIL HOMOCYSTEINE
28	VON WILLEBRANDT FACTOR LATEX AGGLUTINATION TEST	MULTIPLE (TEST VWILLEBRANDT FACTOR)
All FDA-Registered products for this company are displayed above.

Other Products Offered by BIOKIT S.A.:

No products have been listed by this company.

Services Offered by the BIOKIT S.A.:
No services have been listed by this company.

Additional Contact Information for BIOKIT S.A.:
There is no additional contact information for this company.

Competitors of BIOKIT S.A.

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FDA-Registered Company Profile for BIOKIT S.A.

FDA-Registered Products Offered by BIOKIT S.A.

Other Products Offered by BIOKIT S.A.:

Services Offered by the BIOKIT S.A.:

Additional Contact Information for BIOKIT S.A.:

Competitors of BIOKIT S.A.