Consulting Wallah › Device Explorer › IVD & laboratory › Albumin IVD, kit, spectrophotometry
Device Explorer · FDA GUDID · GMDN 59071

Albumin IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used to aid in the diagnosis and monitoring of di

US‑registered devices57in commercial distribution
Companies13labelers on GUDID
Single‑use40%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Horiba Instruments Incorporated1425%
Roche Diagnostics Gmbh1018%
Abbott Ireland814%
Beckman Coulter, Inc.814%
Siemens Healthcare Diagnostics Inc.47%
Medicon Hellas S.A.24%
Vitalscientific24%
Horiba Abx Sas24%

Top labelers

CompanyDevicesShare
Horiba Instruments Incorporated1425%
Roche Diagnostics Gmbh1018%
Abbott Ireland814%
Beckman Coulter, Inc.814%
Siemens Healthcare Diagnostics Inc.47%
Medicon Hellas S.A.24%
Vitalscientific24%
Horiba Abx Sas24%
Stanbio Laboratory, L.P.24%
Sekisui Diagnostics, Llc24%
Fisher Diagnostics12%
Diazyme Laboratories, Inc.12%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Albumin Gen.2AlbuminAlbuminBCP AlbuminBCPAlbumin BCPTinaquant Albumin Gen2Albumin Gen2ALBUMINENVOY 500 ALBUMIN REAGENT KITYumizen C1200 AlbuminABX PENTRA ALBUMIN CPThermo ScientificDimension Vista® Flex® reagent cartridge ALBDimension® Flex® reagent cartridge ALBDiazymePointe Albumin ReagentPointe Albumin on BS480 Analyzer

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

FDA product codes

CodeNameDevices
CIXBromcresol Green Dye-Binding, Albumin23
CIXBROMCRESOL GREEN DYE-BINDING, ALBUMIN16
CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN12
DCFAlbumin, Antigen, Antiserum, Control4
CJWBromcresol Purple Dye-Binding, Albumin2
DEMALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL1

GMDN & GCC registration

  • GMDN code 59071 · non‑implantable
  • Single‑use 40% · sterile 0% · Rx‑only 84% · 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.

No closely related category with 50+ devices.

How many albumin ivd, kit, spectrophotometry products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Albumin IVD, kit, spectrophotometry", from 13 companies. The largest labeler is Horiba Instruments Incorporated with 25% of records.

Which FDA product codes apply?

CIX (Bromcresol Green Dye-Binding, Albumin), CIX (BROMCRESOL GREEN DYE-BINDING, ALBUMIN), CJW (BROMCRESOL PURPLE DYE-BINDING, ALBUMIN), DCF (Albumin, Antigen, Antiserum, Control)

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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