Boditech Med Inc.

Address:43, Geodudanji 1-gil, Dongnae-myeon,Chuncheon Gangwon,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fluorometer, For Clinical Use (KHO) (2) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (2) Automated Occult Blood Analyzer (OOX) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, C-Reactive Protein (DCN) (1)

Premarket Exempt

No Yes

Clear

Boditech TSH Control - 08806133060353 Catalog Number :

Device Class : 1

Duns Number: 689062203

Premarket Exempt : No

Product Code : JLW, KHO

Prescription Use : Yes

Device Count : 1

Boditech TSH Calibrator - 08806133070437 Catalog Number :

Device Class : 1

Duns Number: 689062203

Premarket Exempt : No

Product Code : KHO, JLW

Prescription Use : Yes

Device Count : 1

NuActor Viral RNA Extraction kit - 08806133080603 Catalog Number : UFPK-1

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 12

ichroma™ CRP - 08806679001520 Catalog Number : i-CHOMRA CRP-25

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 25

ichroma™ iFOB - 08806679002718 Catalog Number : CFPC-15

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code : OOX, JJX

Prescription Use : Yes

Device Count : 25

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