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Goldsite Diagnostics Inc.

China·CN-MF-000001353

Last updated September 18, 2026

What Goldsite Diagnostics Inc. makes

Goldsite Diagnostics Inc. manufactures in vitro diagnostic test kits and calibrators for clinical laboratory use. Their product portfolio includes specific assays for measuring proteins, hormones, and markers such as D-Dimer, HbA1c, IgM, and albumin, alongside dedicated calibrators for these testing systems.

The company is based in China and maintains listings for its products in EUDAMED. These devices are categorized as Class A and IVD General products under the applicable regulatory framework.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of products does Goldsite Diagnostics Inc. manufacture?

Goldsite Diagnostics Inc. manufactures in vitro diagnostic test kits and calibrators designed for clinical laboratory use. Their product portfolio includes specific assays for measuring proteins, hormones, and various markers such as D-Dimer, HbA1c, IgM, and albumin, as well as the necessary calibrators to support these testing systems.

Where is Goldsite Diagnostics Inc. based?

Goldsite Diagnostics Inc. is based in China. This location information is provided as part of the company's regulatory profile to identify the origin of the manufacturer.

How are the devices from Goldsite Diagnostics Inc. classified and where are they listed?

The devices produced by Goldsite Diagnostics Inc. are categorized as Class A and IVD General products. These devices are listed in EUDAMED, which is the European database on medical devices used to provide transparency and information regarding products available within the regulatory framework.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: China
Address: No. 1001, Building No.1, GOLDSITE Mansion, No. 9 Rongtian Road, Shenzhen, China
Website: en.goldsite.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 755 26890807
PRRC Contact: Ji Zhou
EUDAMED SRN: CN-MF-000001353
FDA FEI Number: —
DUNS Number: —

Catalogue (256)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Kemilo 25-OH-VD Kit	KM38018	EUDAMED	IVD General	Active
Omlipo SAA Kit	OP52050	EUDAMED	IVD General	Active
FIA Go T3 Kit	FIA22025	EUDAMED	IVD General	Active
Anti-CCP Control Level 3	DM026H	EUDAMED	IVD General	Active
FIA Go cTnI Kit	FIA13025	EUDAMED	IVD General	Active
GPP-100 IgM Kit	GP09020	EUDAMED	IVD General	Active
FIA Go AMH Kit	FIA30025	EUDAMED	IVD General	Active
Kemilo T3 Control	CC017L	EUDAMED	IVD General	Active
Nephstar CRP Kit	DK022	EUDAMED	IVD General	Active
A1M Calibrator	BZ063	EUDAMED	IVD General	Active
CRP Calibrator L	CPBZ204	EUDAMED	IVD General	Active
Kemilo FT4 Kit	KM16060	EUDAMED	IVD General	Active
Nephstar SAA Kit	BK052	EUDAMED	IVD General	Active
Nephstar TRF Kit	DK015	EUDAMED	IVD General	Active
Nephstar Plus bCRP Kit	NP51102	EUDAMED	IVD General	Active
HbA1c Elution Buffer B	GH2400	EUDAMED	IVD General	Active
Nephstar ALB Kit	DK011	EUDAMED	IVD General	Active
Nephstar UsCRP Kit	DK025	EUDAMED	IVD General	Active
Nephstar PAB Kit	DK012	EUDAMED	IVD General	Active
Lp(a) Calibrator	BZ043	EUDAMED	IVD General	Active
GPP-100 BMG Kit	GP62020	EUDAMED	IVD General	Active
Kemilo NT-ProBNP Kit	KM06060	EUDAMED	IVD General	Active
HbA2 & HbF & HbA1c Assay Kit (HPLC)	GHD200	EUDAMED	IVD General	Active
HbA1c Elution Buffer A	GH1800	EUDAMED	IVD General	Active
Kemilo 25-OH-VD Control	CC038L	EUDAMED	IVD General	Active
Omlipo PAB Kit	OP12050	EUDAMED	IVD General	Active
Omlipo AAG Kit	OP13050	EUDAMED	IVD General	Active
Omlipo AAT Kit	OP38050	EUDAMED	IVD General	Active
SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)	CG127025	EUDAMED	IVD General	Active
Kemilo PRL Kit	KM30060	EUDAMED	IVD General	Active
Hemolysis	GHL2000	EUDAMED	IVD General	Active
Nephstar RF Kit	DK023	EUDAMED	IVD General	Active
A1M Control	DM063	EUDAMED	IVD General	Active
Omlipo KAP Kit	OP44050	EUDAMED	IVD General	Active
HbA2 & HbF & HbA1c Calibrator	GHDBZ	EUDAMED	IVD General	Active
Gba-1000	GBA-1000	EUDAMED	Class A	Active
Kemilo TSH Control	CC013M	EUDAMED	IVD General	Active
GPP-100 KAP Kit	GP44020	EUDAMED	IVD General	Active
Nephstar Cys C Kit	DK066	EUDAMED	IVD General	Active
Kemilo T3 Control	CC017H	EUDAMED	IVD General	Active
FIA Go hsCRP & CRP Kit	FIA08025	EUDAMED	IVD General	Active
Kemilo D-Dimer Control	CC010L	EUDAMED	IVD General	Active
Nephstar mALB Kit	DK061	EUDAMED	IVD General	Active
SARS-CoV2 & Influenza A/B Antigen Kit (Colloidal Gold)	CG125005	EUDAMED	IVD General	Active
HbA1c Elution Buffer C	GH3800	EUDAMED	IVD General	Active
Monkeypox Virus Real-time PCR Kit	GPCR130024	EUDAMED	IVD General	Active
Kemilo FT3 Control	CC015M	EUDAMED	IVD General	Active
SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)	CG123001	EUDAMED	IVD General	Active
Kemilo PRL Control	CC030H	EUDAMED	IVD General	Active
Omlipo IgG Kit	OP04100	EUDAMED	IVD General	Active

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