FDA.reportPublic FDA data

PathTezt®

Primary DI
09551020410054
Brand
PathTezt®
Company
BIOCYTECH CORPORATION SDN. BHD.
Model
CTLS-9260604
Device description
Buffered, preservative and lysis the red-blood cell solution.
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
LDWFixative, Acid Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDWFixative, Acid ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551020410054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551020410054095510204100549551020410054

GMDN Terms#

Term, Definition table
TermDefinition
Fixative, acidAn agent containing acid employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.

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
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
09551020410351PathTezt®CG-1024502026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810185250462TherapakTherapak LLCLDW2025-08-11
00810185250486TherapakTherapak LLCLDW2025-08-11
00810185250479TherapakTherapak LLCLDW2025-08-11
00810185250493TherapakTherapak LLCLDW2025-08-11
07312058462673TherapakTherapak LLCLDW2022-12-21
07312058462680TherapakTherapak LLCLDW2022-12-21
00845275005134Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDW2016-09-16