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OPTI CCA TS Accessory Kit

FDA UDI

Class II (US FDA UDI)

by Opti Medical Systems Inc.

Identity

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

Identifiers

Catalog Number
BP7035 FDA UDI
Primary DI / UDI-DI
00894472000145 FDA UDI
510(k) Number
K093280 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 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 CCA TS Accessory Kit by Opti Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K093280 also covers:

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 99e6884e-f99c-4e88-bb05-9198416ea624 35 fields · synced May 30, 2026