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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
Sputum specimen liquefaction/decontamination kit IVD FDA UDI
Device Name
NAC-PAC RED (2.0%) 50ml bottle FDA UDI
Model / Reference
0 FDA UDI
Description
NAC-PAC RED (2.0%) 50ml bottle FDA UDI

Identifiers

Primary DI / UDI-DI
00816085020914 FDA UDI
510(k) Number
K881698 FDA UDI
FDA Product Code
JSK FDA UDI
GMDN Term
Sputum specimen liquefaction/decontamination kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2450 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: Sputum specimen liquefaction/decontamination kit IVD

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 Sputum specimen liquefaction/decontamination kit IVD.

Cleared under the same submission

K881698 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alpha-Tec Systems, Inc.

Sources (1)

  • FDA UDI 68efc3d1-aab9-4f0b-8da6-2fda9850ddab 34 fields · synced May 30, 2026