Afias Tsh-Sp

FDA UDI

Class I (US FDA UDI)

by Boditech Med, Inc.

Identity

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

Identifiers

Catalog Number: SMFP-57 FDA UDI
Primary DI / UDI-DI: 08806133005262 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thyroid stimulating hormone (TSH) IVD, reagent

Afias Tsh-Sp 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-6/VB Analyzer — Boditech Med, Inc. · Class II
AFIAS-6/SP Analyzer — Boditech Med, Inc. · Class I
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 a5a3a267-8af6-4877-81f0-40ada1813865 36 fields · synced May 30, 2026