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B Cassette

FDA UDI

Class II (US FDA UDI)

by Opti Medical Systems Inc.

Identity

Trade Name
B Cassette FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, reagent FDA UDI
Device Name
B Cassette Carton FDA UDI
Model / Reference
1 FDA UDI
Description
B Cassette Carton FDA UDI

Identifiers

Catalog Number
BP7562 FDA UDI
Primary DI / UDI-DI
00894472000237 FDA UDI
510(k) Number
K974784 FDA UDI
FDA Product Code
GKR FDA UDI
GMDN Term
Multiple clinical chemistry enzyme IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry enzyme IVD, reagent

B Cassette by Opti Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry enzyme IVD, reagent.

Cleared under the same submission

K974784 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 ec111924-7a70-4865-b68c-48e13b29277c 35 fields · synced Jun 8, 2026