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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
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Urine testing (cc) - rt & poc
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Urine single test strips (incl. tablets)
Urine single test strips (incl. tablets)
W0101060201
87 devices
Atlas URS 1 Parameter: Glucose, 100 Strips/ Bottle.
Atlas Medical GmbH
·
,
Germany
IVD General
CE/IVDD
Medi-Test Protein 2
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Medi-Test Combi 5L
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Urispec PLUS 5+ LEUKO PLUS
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Urine Analysis Test Strips (Dry Chemistry Method)
Biobase Poct Co., Ltd
·
,
China
IVD General
CE/IVDD
Medi-Test URYXXON® Stick 10
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Urine Analysis Test Strips (Dry Chemistry Method)
Biobase Poct Co., Ltd
·
,
China
IVD General
CE/IVDD
Uri Stix 10GLS
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Urispec PLUS 3 PLUS
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Uri Stix 10
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Medi-Test Combi 5S
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Medi-Test Keton
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
MAU Quantitative Test Kit (Time-Resolved FIA)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Medi-Test Nitrit
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Medi-Test URYXXON® Stick 10
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Urinalysis Strips
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Medi-Test Combi 8L
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Creatinine Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Urispec PLUS 11 SYS PLUS
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
Medi-Test Combi 11
Open recall
MACHEREY-NAGEL GmbH & Co. KG
·
,
Germany
Class B
CE/IVDR
IX 1038121-2
Active
Valid to May 2028
FDA 510(k)
K991927
Active
Cleared 17 Sep 1999
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