Tris-Buffered Saline

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: Tris-Buffered Saline FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Model / Reference: 5365 FDA UDI

Identifiers

Primary DI / UDI-DI: M52553650 FDA UDI
510(k) Number: K840329 FDA UDI
FDA Product Code: GGP FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7290 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

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: Buffered sample diluent IVD

Tris-Buffered Saline by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ADVIA Centaur® T4 DIL — Siemens Healthcare Diagnostics · Class II
Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I

Cleared under the same submission

K840329 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 II	Pending data

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Manufacturer

Manufacturer: Helena Laboratories, Corp.

Sources (1)

FDA UDI 4a39ef78-8fad-459f-af9c-38fcf47e0336 34 fields · synced Jun 9, 2026