Clearblue by NC

GUDID 07350014630285

Naturalcycles Nordic AB

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software
Primary Device ID07350014630285
NIH Device Record Key282eaca8-d164-4806-a148-fb440f5f2a0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearblue by NC
Version Model Number0001
Company DUNS352550104
Company NameNaturalcycles Nordic AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107350014630285 [Primary]

FDA Product Code

PYTDevice, Fertility Diagnostic, Contraceptive, Software Application

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-22
Device Publish Date2021-11-12

Devices Manufactured by Naturalcycles Nordic AB

17350014630145 - Natural Cycles Ovulation Tests2023-05-22
17350014630152 - Natural Cycles Pregnancy Tests2023-05-22
07350014630100 - Cycle Tracking2023-04-27
07350014630155 - Natural Cycles2022-10-31 Test, Pregnancy, Hcg, Over The Counter
07350014630148 - Natural Cycles2022-06-10 Test, Luteinizing Hormone (Lh), Over The Counter
07350014630285 - Clearblue by NC2021-11-22
07350014630285 - Clearblue by NC2021-11-22
07350014630209 - Natural Cycles2020-02-17 Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy str
07350014630124 - Natural Cycles2019-03-12

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