← Back to catalogue

Alpha-Tec Systems

FDA UDI

Class I (US FDA UDI)

by Alpha-Tec Systems, Inc.

Identity

Trade Name
Alpha-Tec Systems FDA UDI
Generic Name
Faecal specimen collection kit IVD, home-use FDA UDI
Device Name
PVA (Zn)/10% Formalin/Clean Vial bag kit FDA UDI
Model / Reference
0 FDA UDI
Description
PVA (Zn)/10% Formalin/Clean Vial bag kit FDA UDI

Identifiers

Primary DI / UDI-DI
00816085022468 FDA UDI
510(k) Number
K881698 FDA UDI
FDA Product Code
LDZ FDA UDI
GMDN Term
Faecal specimen collection kit IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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: Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems by Alpha-Tec Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal specimen collection kit IVD, home-use.

Cleared under the same submission

K881698 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alpha-Tec Systems, Inc.

Sources (1)

  • FDA UDI 2edfc63e-2413-4fcc-b504-4a270138d2cc 34 fields · synced Jun 8, 2026