Who else makes this device?

Name: OLO CBC Test Kit
Brand: OLO CBC Test Kit

Hematology › Automated Hematology DevicesCounter, Differential Cell

OLO CBC Test Kit

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GKZ
Manufacturer	City	Province	Registered as	Device types
VTech Communications Ltd	Dongguan	Guangdong	Contract manufacturer	5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Onechipdx Biotech (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for OLO CBC Test Kit
Listed by	S.D. Sight Diagnostics, Ltd., Israel
FDA product code	GKZ
Device type	Counter, Differential Cell
Device class	Class 2
Regulation	21 CFR 864.5220
Record published	2020-02-09
Record revised	2024-11-14 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment humidity 10 to 80 % RH; Storage environment temperature 18 to 26 °C
Packaging	Pack of 25, case of 8
Distribution end date	2024-09-30

Catalogue Numbers

Catalogue numbers for OLO CBC Test Kit
Catalogue number	Size	Status
TK1		Withdrawn

Same Product Code

Other products under the same FDA product code
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Simultest	Becton, Dickinson AND Company	10
BD FACSCanto™	Becton, Dickinson AND Company	10
FACSCanto	Becton, Dickinson AND Company	7
BD Multitest	Becton, Dickinson AND Company	6
Coulter AcT	Beckman Coulter, Inc.	6
BD™ Multi-Check	Becton, Dickinson AND Company	6
BD Tritest	Becton, Dickinson AND Company	6
Coulter LH	Beckman Coulter, Inc.	5
HemoScreen	Pixcell Medical Inc.	5

Showing 12 of 245. All products under Counter, Differential Cell

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K211840	2022-05-09

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of OLO CBC Test Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Sight Diagnostics, Ltd.	UDI-DI	2024-05-13	Class II	Process control	One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specifica	7,450 units (2,800 US, 4,650 OUS)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.