Consulting Wallah › Device Explorer › IVD & laboratory › Total aspartate aminotransferase (AST) IVD, kit, s
Device Explorer · FDA GUDID · GMDN 52954

Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total aspartate aminotransferase (AST) in a clinical specimen, using a spectrophotometry method.

US‑registered devices70in commercial distribution
Companies16labelers on GUDID
Single‑use37%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Horiba Instruments Incorporated1217%
Roche Diagnostics Gmbh1116%
Beckman Coulter, Inc.811%
Siemens Healthcare Diagnostics Inc.710%
Abbott Ireland710%
Vitalscientific57%
Medicon Hellas S.A.34%
Randox Laboratories Limited34%

Top labelers

CompanyDevicesShare
Horiba Instruments Incorporated1217%
Roche Diagnostics Gmbh1116%
Beckman Coulter, Inc.811%
Siemens Healthcare Diagnostics Inc.710%
Abbott Ireland710%
Vitalscientific57%
Medicon Hellas S.A.34%
Randox Laboratories Limited34%
Stanbio Laboratory, L.P.34%
Abbott Laboratories34%
Horiba Abx Sas23%
Abbott Gmbh23%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aspartate Aminotransferase acc. to IFCC IIAspartate Aminosransferase acc. to IFCC with pyrAspartate Aminotransferase Kit (Colorimetric MetAST/GOTASPARTATE AMINOTRANSFERASE (AST)Aspartate Aminotransferase acc to IFCC without pAspartate Aminotransferase acc to IFCC with pyriAspartate aminotransferase withwithout pyridoxalAspartate aminotransferase acc to IFCC withwithoAST/GOT 4+1 SLENVOY 500 AST REAGENT KITYumizen C1200 ASTABX PENTRA AST CPDimension Vista® Flex® reagent cartridge ASTDimension® Flex® reagent cartridge ASTAST (SGOT) Reagent Set

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
CITNadh oxidation/nad reduction, ast/sgot33
CITNadh Oxidation/Nad Reduction, Ast/Sgot30
CISHydrazone Colorimetry, Ast/Sgot2
CKANadh Oxidation/Nad Reduction, Alt/Sgpt1

GMDN & GCC registration

  • GMDN code 52954 · non‑implantable
  • Single‑use 37% · sterile 0% · Rx‑only 76% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many total aspartate aminotransferase (ast) ivd, kit, spectrophotometry products are registered in the US?

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry", from 16 companies. The largest labeler is Horiba Instruments Incorporated with 17% of records.

Which FDA product codes apply?

CIT (Nadh oxidation/nad reduction, ast/sgot), CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), CIS (Hydrazone Colorimetry, Ast/Sgot), CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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