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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
Address 2:
City: LLISSA D'AMUNT, BARCELONA
State
Zip / Postal Code: 08186
County:
Country: SP
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: SP
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: SP
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: MA
Zip Code: 02421
Country: SP
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 C-REACTIVE PROTEIN LATEX AGGLUTINATION TESTS MULTIPLE PRODUCT NAMES
5 CHEMILUMINESCENT PTH REAGENT ARCHITECT INTACT PTH
6 CHEMILUMINESCENT SHBG TEST ARCHITECT SHBG
7 CHEMILUMINESCENT THEOPHYLLINE CALIBRATORS ARCHITECT ITHEOPHYLLINE CALIBRATORS
8 CHEMILUMINESCENT THEOPHYLLINE REAGENT ARCHITECT ITHEOPHYLLINE REAGENTS
9 CHEMILUMINISCENT DHEA-S TEST ARCHITECT DHEA-S
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 MUTIPLE (QUANTIA FERRITIN STANDARD)
20 PROTEINS CALIBRATOR MULTIPLE (QUANTIA LP(A) 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.






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