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AIA-PACK TSH 3rd-Gen

FDA UDI

Class II (US FDA UDI)

by Tosoh Corp.

Identity

Trade Name
AIA-PACK TSH 3rd-Gen FDA UDI
Generic Name
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
N/A FDA UDI

Identifiers

Primary DI / UDI-DI
14560189210056 FDA UDI
FDA Product Code
JLW FDA UDI
GMDN Term
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

AIA-PACK TSH 3rd-Gen by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tosoh Corp.

Sources (1)

  • FDA UDI a2d2c700-749f-433c-a2f2-36159b804def 34 fields · synced Jun 6, 2026