FDA.reportPublic FDA data

PathTezt®

Primary DI
09551020410368
Brand
PathTezt®
Company
BIOCYTECH CORPORATION SDN. BHD.
Model
GS-2500
Device description
To protect the stained cell sample on the slide for microscopic examination.
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KEWSlides, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551020410368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551020410368095510204103689551020410368

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
865773902
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551020410009PathTezt®PTIA-20212026-03-11
09551020410016PathTezt®LBC-20092026-03-11
09551020410030PathTezt®NGPCS-200920 2026-03-11
09551020410047PathTezt®PCS-9262026-03-11
09551020410054PathTezt®CTLS-9260604 2026-03-11
09551020410078PathTezt®NGF-0525100 2026-03-11
09551020410085PathTezt®UCF-08131002026-03-11
09551020410092PathTezt®CS-361002026-03-11
09551020410108PathTezt®PCS-2009202026-03-11
09551020410115PathTezt®EV-600102026-03-11
09551020410146PathTezt®PDR-10002026-03-11
09551020410221PathTezt®PCS-200910E2026-03-11
09551020410238PathTezt®PCS-2009052026-03-11
09551020410245PathTezt®PCS-2009032026-03-11
09551020410252PathTezt®PCS-2009012026-03-11
09551020410283PathTezt®EV-600052026-03-11
09551020410313PathTezt®DF-25082026-03-11
09551020410320PathTezt®IS-361002026-03-11
09551020410337PathTezt®US-361002026-03-11
09551020410344PathTezt®HS-361002026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975800980446JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980453JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980460JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980491JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980507JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980521JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980538JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980545JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980552JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980569JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980576JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980583JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980590JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980606JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980613JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980620JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980637JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980644JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980675JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980682JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980699JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980705JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980712JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980729JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980736JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980743JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980750JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980767JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980774JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25
06975800980781JWCHEMYancheng Jingwei Chemicals Co., LtdKEW2022-11-25