Pointe Meprobamate Control (125 ng/mL) Level 2

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Meprobamate Control (125 ng/mL) Level 2 FDA UDI
Generic Name: Carisoprodol IVD, control FDA UDI
Device Name: Pointe Meprobamate Control (125 ng/mL) Level 2 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-MB0756-5 FDA UDI
Description: Pointe Meprobamate Control (125 ng/mL) Level 2 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-MB0756-5 FDA UDI
Primary DI / UDI-DI: 00811727018458 FDA UDI
FDA Product Code: LAS FDA UDI
GMDN Term: Carisoprodol IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Carisoprodol IVD, control

Pointe Meprobamate Control (125 ng/mL) Level 2 by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Carisoprodol IVD, control.

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Immunalysis — Immunalysis Corporation · Class I
Pointe Meprobamate Control (75 ng/mL) Level 1 — POINTE SCIENTIFIC, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Pointe Scientific, Inc.

Sources (1)

FDA UDI c4fa5774-292a-48db-9cbf-a36056f2ed81 36 fields · synced Jun 1, 2026