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Device Explorer · FDA GUDID · GMDN 30590

Multiple coagulation marker IVD, control

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated componen

US‑registered devices184in commercial distribution
Companies24labelers on GUDID
Single‑use63%of device records
Sterile0%labelled sterile
Prescription55%Rx‑only share
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Share of device records

George King Bio-Medical, Inc3217%
Medtronic, Inc.2815%
Accriva Diagnostics Holdings, Inc.2011%
Siemens Healthcare Diagnostics Products Gmbh148%
Instrumentation Laboratory Company137%
Fisher Diagnostics105%
Haemonetics Corporation95%
Bio-Rad Laboratories, Inc.84%

Top labelers

CompanyDevicesShare
George King Bio-Medical, Inc3217%
Medtronic, Inc.2815%
Accriva Diagnostics Holdings, Inc.2011%
Siemens Healthcare Diagnostics Products Gmbh148%
Instrumentation Laboratory Company137%
Fisher Diagnostics105%
Haemonetics Corporation95%
Bio-Rad Laboratories, Inc.84%
Helena Laboratories Corporation63%
Precision Biologic Inc53%
R 2 Diagnostics, Inc.53%
Eurotrol B.V.53%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

5-PLASMA Bivalirudin ControlCOAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)ROTEM®BIOPHEN ABNORMAL CONTROL PLASMABIOPHEN NORMAL CONTROL PLASMASTA® - System Control N + PSTA® - Coag Control (N + ABN) PLUSSTA® - Liatest® Control N + PNAExpertCor RoutineREAADS Coagulation Control 2REAADS Coagulation Control 1IDG/SanzayLyphochek

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

FDA product codes

CodeNameDevices
GGNPlasma, Coagulation Control98
GGNPLASMA, COAGULATION CONTROL35
GGCControl, Plasma, Abnormal19
JBPACTIVATED WHOLE BLOOD CLOTTING TIME15
JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES13
GGCCONTROL, PLASMA, ABNORMAL9

GMDN & GCC registration

  • GMDN code 30590 · non‑implantable
  • Single‑use 63% · sterile 0% · Rx‑only 55% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 3

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

How many multiple coagulation marker ivd, control products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple coagulation marker IVD, control", from 24 companies. The largest labeler is George King Bio-Medical, Inc with 17% of records.

Which FDA product codes apply?

GGN (Plasma, Coagulation Control), GGN (PLASMA, COAGULATION CONTROL), GGC (Control, Plasma, Abnormal), JBP (ACTIVATED WHOLE BLOOD CLOTTING TIME)

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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