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BIOKIT, S.A.

Spain·ES-MF-000002406

Last updated September 17, 2026

Information

Country
Spain
Address
7, AV. CAN MONTCAU, LLIÇÀ D´AMUNT (BARCELONA), Spain
Website
werfen.com
LinkedIn
—
Facebook
—
Phone
+34 938609000
PRRC Contact
Àngels Roma
EUDAMED SRN
ES-MF-000002406
FDA FEI Number
3002806557
DUNS Number
460055742

Catalogue (105)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Rubajet 500 TESTS 300024012
FDA UDI
Class IIUnknown
Biokit RPR 500 TESTS 300625550
FDA UDI
Class IIActive
Rubagen 100 TESTS 300024001
FDA UDI
Class IIUnknown
Rubajet 100 TESTS 300024011
FDA UDI
Class IIUnknown
biokitHSV-2 300028001
FDA UDI
Class IIUnknown
Rheumajet CRP 100 TESTS 3000-7051
FDA UDI
Class IIUnknown
Rheumajet RF 50 TESTS 300027034
FDA UDI
Class IIActive
Rheumajet RF 100 TESTS 3000-7033
FDA UDI
Class IIActive
CRP Titer Control 300021061
FDA UDI
Class IIUnknown
Color Mono 50 TESTS 3000-1005
FDA UDI
Class IIUnknown
ASO Titer Control 300021060
FDA UDI
Class IUnknown
RF Titer Control 300021062
FDA UDI
Class IIUnknown
BIO-FLASH Cuvette Waste Bin 3410-0824
EUDAMED
Class AActive
D-Dimer Calibrator 01R1001
EUDAMED
Class CActive
Quantia Digitoxin Control 6K57-02
EUDAMED
Class CActive
BIO-FLASH Narrow Tube Sample Adaptor 3410-0872
EUDAMED
Class AActive
IgA 3000-2268
EUDAMED
Class BActive
Alinity c β2-Microglobulin Reagent Kit 01R0920
EUDAMED
Class CActive
sTfR (II) Controls 3000-2339
EUDAMED
IVD GeneralActive
Bio-Flash 3710-0344
EUDAMEDFDA UDI
Class AActive
BIO-FLASH Sample Cups 3000-8209
EUDAMED
Class AActive
Architect 25-Oh Vitamin D 100t, Vitamin D 500t, Vitamin D Calibrators, Vitamin D Controls K110619
FDA 510(k)
Class IIActive
ADVIA Centaur EBV-VCA IgM K233606
FDA 510(k)
Class IActive
Architect Idigoxin And Architect Idigoxin Calibrators, Models 1p32-25 And Ip32-01 K082953
FDA 510(k)
Class IIActive
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls K213987
FDA 510(k)
Class IIActive
Architect I Theophylline Reagents And Calibrators (a-F) K070810
FDA 510(k)
Class IIActive
Quantia Beta-2 Microglobulin K050613
FDA 510(k)
Class IIActive
Quantia A1-At K050596
FDA 510(k)
Class IIActive
Architect Shbg Reagent Kit, Architect Shbg Calibrator Kit, And Architect Shbg Control Kit With Models, 8k26-25, 8k26-01 K060818
FDA 510(k)
Class IActive
ADVIA Centaur Herpes-2 IgG K181334
FDA 510(k)
Class IIActive
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls K243575
FDA 510(k)
Class IIActive
ADVIA Centaur Herpes-1 IgG K181333
FDA 510(k)
Class IIActive
Architect Ivancomycin Reagents And Architect Ivancomycin Calibrators, Models: 1p30-25 And 1p30-01 K072036
FDA 510(k)
Class IIActive
Lp(a) Calibrators, And Lp(a) Controls K132400
FDA 510(k)
Class IIActive
Architect C-Peptide Calibrators, And Architect C-Peptide Controls, Models 3l53-01, 3l53-10 K082141
FDA 510(k)
Class IIActive
Architect Dhea-S Calibrators (a-F) And Controls (low, Medium And High) K060027
FDA 510(k)
Class IActive
Architect Shbg K152185
FDA 510(k)
Class IActive
ADVIA Centaur EBV-EBNA IgG K233605
FDA 510(k)
Class IActive
Architect Intact Pth Reagents, Calibrators (a-F) And Controls (low, Medium, High), Models 8k25-20, 8k25-25, 8k25-01 K063232
FDA 510(k)
Class IIActive
Architect Ivancomycin K123947
FDA 510(k)
Class IIActive
Quantia La(a) K050487
FDA 510(k)
Class IIActive
Quantia Beta-2 Microglobulin, Model: 302822307 K072078
FDA 510(k)
Class IIActive
HemosIL VWF:RCo 0020300900
EUDAMED
Class BActive
IgG 3000-2269
EUDAMED
Class BActive
Alinity c A-1-AGP Reagent Kit 01R0820
EUDAMED
Class BActive
Quantia Lp(a) 7K00-03
EUDAMED
Class BActive
Quantia PROTEINS Standard 6K45-03
EUDAMED
Class BActive
Lp(a) 3000-2292
EUDAMED
Class BActive
Lp(a) Control 5P84-11
EUDAMEDFDA UDI
Class BActive
CRP plus Calibrator 3000-2093
EUDAMED
Class CActive

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