Ammonia / Iron Standard, Level C

FDA UDI

Class II (US FDA UDI)

by Verichem Laboratories, Inc.

Identity

Trade Name: Ammonia / Iron Standard, Level C FDA UDI
Generic Name: Ammonia IVD, calibrator FDA UDI
Device Name: Calibrator /Calibration Verifier FDA UDI
Model / Reference: 9043 FDA UDI
Description: Calibrator /Calibration Verifier FDA UDI

Identifiers

Primary DI / UDI-DI: 00852553007261 FDA UDI
510(k) Number: K972333 FDA UDI
FDA Product Code: JIX FDA UDI
GMDN Term: Ammonia IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Ammonia IVD, calibrator

Ammonia / Iron Standard, Level C by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ammonia IVD, calibrator.

Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
POINTE SCIENTIFIC Ammonia Standard 1 — POINTE SCIENTIFIC, INC. · Class I
POINTE SCIENTIFIC Ammonia Standard 5 — POINTE SCIENTIFIC, INC. · Class I
Ammonia / Iron Standard, Level F — VERICHEM LABORATORIES, INC. · Class II
Ammonia Standard Kit — VERICHEM LABORATORIES, INC. · Class II

Cleared under the same submission

K972333 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: Verichem Laboratories, Inc.

Sources (1)

FDA UDI a3c5be79-b6bc-49ab-849e-74d3d4fbabf2 35 fields · synced May 30, 2026