AFIAS-6/SP Analyzer

FDA UDI

Class I (US FDA UDI)

by Boditech Med, Inc.

Identity

Trade Name: AFIAS-6/SP Analyzer FDA UDI
Generic Name: Thyroid stimulating hormone (TSH) IVD, reagent FDA UDI
Device Name: 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. FDA UDI
Model / Reference: FPRR020-4 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: FPRR020-4 FDA UDI
Primary DI / UDI-DI: 08806133010075 FDA UDI
510(k) Number: K170232 FDA UDI
FDA Product Code: KHO FDA UDI
JLW FDA UDI
GMDN Term: Thyroid stimulating hormone (TSH) IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2560 FDA UDI
862.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thyroid stimulating hormone (TSH) IVD, reagent

AFIAS-6/SP Analyzer by Boditech Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone (TSH) IVD, reagent.

AIMSTEP THYROID SCREEN — GERMAINE LABORATORIES, INC. · Class II
Boditech TSH Calibrator — Boditech Med, Inc. · Class I
Boditech TSH Control — Boditech Med, Inc. · Class II
AFIAS TSH-SP — Boditech Med, Inc. · Class I
AFIAS-6/VB Analyzer — Boditech Med, Inc. · Class II
AFIAS TSH-VB — Boditech Med, Inc. · Class II

Cleared under the same submission

K170232 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Boditech Med, Inc.

Sources (1)

FDA UDI bdf0f8da-ef9c-4a00-b6c6-beed72f0d357 36 fields · synced May 31, 2026