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Aia-Pack Pa Calibration Verification Test Set

FDA UDI

Class I (US FDA UDI)

by Tosoh Corp.

Identity

Trade Name
AIA-PACK PA CALIBRATION VERIFICATION TEST SET FDA UDI
Generic Name
Total prostate specific antigen (tPSA) IVD, control FDA UDI
Model / Reference
n/a FDA UDI

Identifiers

Primary DI / UDI-DI
04560189211971 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Total prostate specific antigen (tPSA) IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total prostate specific antigen (tPSA) IVD, control

Aia-Pack Pa Calibration Verification Test Set by Tosoh Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total prostate specific antigen (tPSA) IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tosoh Corp.

Sources (1)

  • FDA UDI b3f6c75c-7a4c-4937-ba3f-1165f887bbe0 34 fields · synced May 30, 2026