Boditech Med Inc.

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

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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) (4) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (4) Automated Occult Blood Analyzer (OOX) (2) Clinical Sample Concentrator (JJH) (1) System, Test, C-Reactive Protein (DCN) (1)

Premarket Exempt

No Yes

Clear

AFIAS iFOB with AFIAS-50 - 08806133005255 Catalog Number : CFPO-15-1

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code : OOX

Prescription Use : Yes

Device Count : 25

AFIAS TSH-SP - 08806133005262 Catalog Number : SMFP-57

Device Description : AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunof AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples.

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code : KHO, JLW

Prescription Use : Yes

Device Count : 24

AFIAS TSH-VB - 08806133005279 Catalog Number : SMFP-58

Device Description : AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunof AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid indiciduals.

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code : JLW, KHO

Prescription Use : Yes

Device Count : 24

AFIAS-50 - 08806133010068 Catalog Number : FPRR022

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

AFIAS-6/SP Analyzer - 08806133010075 Catalog Number : FPRR020-4

Device Description : AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples.

Device Class : 1

Duns Number: 689062203

Premarket Exempt : No

Product Code : KHO, JLW

Prescription Use : Yes

Device Count : 1

AFIAS-6/VB Analyzer - 08806133010082 Catalog Number : FPRR020-5

Device Description : AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at c AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in venous whole blood samples..

Device Class : 1

Duns Number: 689062203

Premarket Exempt : No

Product Code : JLW, KHO

Prescription Use : Yes

Device Count : 1

ichroma Reader - 08806133010099 Catalog Number : FPRR001

Device Class : 2

Duns Number: 689062203

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 1

ALFIS-3 - 08806133010136 Catalog Number : FPRR028

Device Description : FLUOROMETER FOR CLINICAL USE

Device Class :

Duns Number: 689062203

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

NuActor - 08806133010242 Catalog Number :

Device Class : 1

Duns Number: 689062203

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

ichroma Reader - 08806133032008 Catalog Number : FPRR001

Device Class : 2

Duns Number: 689062203

Premarket Exempt : No

Product Code : OOX

Prescription Use : Yes

Device Count : 1

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