Consulting Wallah › Device Explorer › IVD & laboratory › Microplate reader IVD, automated/semi-automated
Device Explorer · FDA GUDID · GMDN 57862

Microplate reader IVD, automated/semi-automated

An electrically-powered automated or semi-automated laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a sepa

US‑registered devices111in commercial distribution
Companies9labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Agilent Technologies, Inc.7769%
Tecan Austria Gmbh1312%
Biobase Biodustry(Shandong)Co., Ltd.109%
Bio-Rad Laboratories, Inc.33%
Monobind, Inc.33%
Diagnostic Automation, Inc.22%
Applied Biocode, Inc.11%
Arlington Scientific, Inc.11%

Top labelers

CompanyDevicesShare
Agilent Technologies, Inc.7769%
Tecan Austria Gmbh1312%
Biobase Biodustry(Shandong)Co., Ltd.109%
Bio-Rad Laboratories, Inc.33%
Monobind, Inc.33%
Diagnostic Automation, Inc.22%
Applied Biocode, Inc.11%
Arlington Scientific, Inc.11%
Ortho-Clinical Diagnostics, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIOBASESH1MSELUXSH1FSELUXSH1M-SISH1MG-SISH1MF-SISH1MFG-SISH1M2-SISH1M2G-SISH1M2F-SISH1M2FG-SISH1F-SISH1FG-SIEPOCH2NSXCTELx808U-SIELx808AESKU

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

FDA product codes

CodeNameDevices
JJQCOLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE78
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use22
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Us6
JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE3
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US2
OOIReal Time Nucleic Acid Amplification System1

GMDN & GCC registration

  • GMDN code 57862 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 2% · 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

Area/Surface Area (Square meter) · 1

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

How many microplate reader ivd, automated/semi-automated products are registered in the US?

111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microplate reader IVD, automated/semi-automated", from 9 companies. The largest labeler is Agilent Technologies, Inc. with 69% of records.

Which FDA product codes apply?

JJQ (COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE), JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Us), JQW (STATION, PIPETTING AND DILUTING, FOR CLINICAL USE)

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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