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We
Declaration of Conformity
NovaTec Immundiagnostica GmbH
Waldstrasse 23 A6
63128 Dietzenbach
herewith declare under our own responsibility, that the products as per
attached product list are in accordance with the requirements of the IVD
Directive 98/79/EC of the European Parliament and Council of Oct.27, 1998 in
regard to in vitro diagnostic medical devices (IVDs).
The accordance was shown by conformity assessment procedures in
Annex III (2 – 5).
Dietzenbach 2013-04-03
Dr. Claudia Rezmer
Management Representative

Prod. No. Prod. No. Name and Description
NovaTec Mikrogen
ADVA0010AW 810202 Adenovirus IgA
ADVG0010AW 810200 Adenovirus IgG
ADVM0010AW 810201 Adenovirus IgM
ASCG0020AW 810251 Ascaris lumbricoides IgG
BOPA0030AW 810204 Bordetella pertussis IgA
BOPG0030AW 810203 Bordetella pertussis IgG
BOPM0030AW 810269 Bordetella pertussis IgM
BRUG0050AW 810252 Brucella IgG
BRUM0050AW 810253 Brucella IgM
CANA0060AW 810207 Candida albicans IgA
CANG0060AW 810205 Candida albicans IgG
CANM0060AW 810206 Candida albicans IgM
CHAG0560AW 810254 Chagas (Trypanosoma cruzi) IgG
CORG5009AW 810214 Corynebacterium diphtheriae toxin 5S IgG
PCORG009AW 810215 Corynebacterium diphtheriae toxin 5S IgG
plus
COX1G060AW 810257 Coxiella burnetii (Q-Fever) Phase 1 IgG
COX2G060AW 810258 Coxiella burnetii (Q-Fever) Phase 2 IgG
COX2M060AW 810259 Coxiella burnetii (Q-Fever) Phase 2 IgM
DENG0120AW 810260 Dengue Virus IgG
DENM0120AW 810261 Dengue Virus IgM
ECHG0130AW 810262 Echinococcus IgG
ENTG0140AW 810263 Entamoeba histolytica IgG
HSVG0250AW 810216 Herpes simplex Virus 1+2 (HSV) IgG
HSVM0250AW 810217 Herpes simplex Virus 1+2 (HSV) IgM
HSV1G050AW 810218 Herpes simples Virus 1 (HSV 1) IgG
HSV1M050AW 810219 Herpes simplex Virus 1 (HSV 1) IgM
HSV2G054AW 810220 Herpes simplex Virus 2 (HSV 2) IgG
HSV2M054AW 810221 Herpes simplex Virus 2 (HSV 2) IgM
INFA0290AW 810224 Influenza A IgA
INFG0290AW 810222 Influenza A IgG
INFM0290AW 810223 Influenza A IgM
INFA0300AW 810227 Influenza B IgA
INFG0300AW 810225 Influenza B IgG
INFM0300AW 810226 Influenza B IgM
LEIG0310AW 810264 Leishmania IgG
MEAG0330AW 810228 Measles Virus IgG
MEAM0330AW 810229 Measles Virus IgM
MUMG0340AW 810230 Mumps Virus IgG
MUMM0340AW 810231 Mumps Virus IgM
MYCA0350AW 810234 Mycoplasma pneumoniae IgA
MYCG0350AW 810232 Mycoplasma pneumoniae IgG
MYCM0350AW 810233 Mycoplasma pneumoniae IgM

PAIA0360AW 810236 Parainfluenza Virus 1,2,3 IgA
PAIG0360AW 810235 Parainfluenza Virus 1,2,3 IgG
RSVA0380AW 810239 Respiratory syncytial Virus (RSV) IgA
RSVG0380AW 810237 Respiratory syncytial Virus (RSV) IgG
RSVM0380AW 810238 Respiratory syncytial Virus (RSV) IgM
SCHG0410AW 810265 Schistosoma mansoni IgG
TAEG0420AW 810266 Taenia solium IgG
TETG5043AW 810243 Clostridium tetani toxin 5S IgG
PTETG043AW 810244 Clostridium tetani toxin 5S IgG plus
TOCG0450AW 810267 Toxocara canis IgG
TRIG0480AW 810268 Trichinella spiralis IgG
VZVA0490AW 810250 Varicella-Zoster Virus (VZV) IgA
VZVG0490AW 810248 Varicella-Zoster Virus (VZV) IgG
VZVM0490AW 810249 Varicella-Zoster Virus (VZV) IgM