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OPTI Accessory Kit

FDA UDI

Class I (US FDA UDI)

by Opti Medical Systems Inc.

Identity

Trade Name
OPTI Accessory Kit FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Device Name
OPTI CCA Analyzer accessory kit FDA UDI
Model / Reference
1 FDA UDI
Description
OPTI CCA Analyzer accessory kit FDA UDI

Identifiers

Catalog Number
GD7045 FDA UDI
Primary DI / UDI-DI
00894472000077 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

OPTI Accessory Kit by Opti Medical Systems Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metabolic profile clinical chemistry analyser IVD, portable, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Opti Medical Systems Inc.

Sources (1)

  • FDA UDI 1373c3a4-f37d-4c84-a39a-b367936a89a9 34 fields · synced Jun 8, 2026