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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Multiple Calibrator	SPBZ105	EUDAMED	IVD General	Active
FIA Go T4 Kit	FIA23025	EUDAMED	IVD General	Active
Nephstar IgM Kit	DK009	EUDAMED	IVD General	Active
FIA Go D-Dimer Kit	FIA15025	EUDAMED	IVD General	Active
Nephstar AAG Kit	DK013	EUDAMED	IVD General	Active
Omlipo C3 Kit	OP33050	EUDAMED	IVD General	Active
GPP-100 mALB Kit	GP61020	EUDAMED	IVD General	Active
Omlipo LAM Kit	OP45050	EUDAMED	IVD General	Active
ASO Calibrator	ALBZ021	EUDAMED	IVD General	Active
Nephstar HbA1c Kit	DK072	EUDAMED	IVD General	Active
Omlipo Lp(a) Kit	OP43050	EUDAMED	IVD General	Active
GPP-100 TRF Kit	GP15020	EUDAMED	IVD General	Active
kappa-FLC Control Level 2	DM092H	EUDAMED	IVD General	Active
FIA Go Free T3 Kit	FIA28025	EUDAMED	IVD General	Active
CER Control	CEDM018	EUDAMED	IVD General	Active
Omlipo UsCRP Kit	OP25100	EUDAMED	IVD General	Active
GPP-100 RF Kit	GP23020	EUDAMED	IVD General	Active
GPP-100 Anti-CCP Kit	GP26020	EUDAMED	IVD General	Active
Kemilo PCT Kit	KM05060	EUDAMED	IVD General	Active
Kemilo PCT Control	CC005	EUDAMED	IVD General	Active
RBP Control	DM064	EUDAMED	IVD General	Active
Time resolved Fluoroimmunoassay Analyzer	FIA Go	EUDAMED	Class A	Active
Nephstar Apo A1 Kit	DK041	EUDAMED	IVD General	Active
FIA Go VB12 Kit	FIA85024	EUDAMED	IVD General	Active
mALB Control	MADM061	EUDAMED	IVD General	Active
Nephstar Lp(a) Kit	DK043	EUDAMED	IVD General	Active
GPP-100 Cys C Kit	GP66020	EUDAMED	IVD General	Active
Nephstar BMG Kit	DK062	EUDAMED	IVD General	Active
HbA1c Elution Buffer A	GH1400	EUDAMED	IVD General	Active
Nephstar Plus HbA1c Kit	NP72025	EUDAMED	IVD General	Active
FIA Go HbA1c Kit	FIA24025	EUDAMED	IVD General	Active
Kemilo D-Dimer Kit	KM10060	EUDAMED	IVD General	Active
Kemilo TB-HCG Kit	KM09060	EUDAMED	IVD General	Active
kappa-FLC Calibrator	BZ092	EUDAMED	IVD General	Active
Apo A1 Control	DM041	EUDAMED	IVD General	Active
Kemilo TB-HCG Kit	KM09018	EUDAMED	IVD General	Active
Buffer H	ARHL001	EUDAMED	Class A	Active
Omlipo Apo A1 Kit	OP41050	EUDAMED	IVD General	Active
Omlipo TRF Kit	OP15050	EUDAMED	IVD General	Active
CRP Calibrator M	CPBZ104	EUDAMED	IVD General	Active
Monkeypox Virus Real-time PCR Kit	GPCR130048	EUDAMED	IVD General	Active
Omlipo IgM Kit	OP09100	EUDAMED	IVD General	Active
GPP-100 A1M Kit	GP63020	EUDAMED	IVD General	Active
GPP-100 FR-CRP Kit	GP56020	EUDAMED	IVD General	Active
Omlipo Urine IgG Kit	OP67050	EUDAMED	IVD General	Active
Nephstar ASO Kit	DK021	EUDAMED	IVD General	Active
FIA Go FSH Kit	FIA46025	EUDAMED	IVD General	Active
Omlipo HPT Kit	OP16050	EUDAMED	IVD General	Active
FIA Go NT-proBNP Kit	FIA14025	EUDAMED	IVD General	Active
Specific Protein Analyzer	GPP-100	EUDAMED	Class A	Active

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