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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Kemilo PROG Kit	KM08018	EUDAMED	IVD General	Active
Apo B Control	DM042	EUDAMED	IVD General	Active
HbA1c Assay Kit (HPLC)	GHB100	EUDAMED	IVD General	Active
Multiple Control	SPDM205	EUDAMED	IVD General	Active
Specific Protein Analyzer	Nephstar	EUDAMED	Class A	Active
Kemilo TSH Control	CC013H	EUDAMED	IVD General	Active
Omlipo IgA Kit	OP01050	EUDAMED	IVD General	Active
Sample Diluent	NSDY110	EUDAMED	Class A	Active
Automatic HPLC HbA1c Analyzer	GSH-60	EUDAMED	Class A	Active
GPP-100 HbA1c Kit	GP72020	EUDAMED	IVD General	Active
FIA Go PRL Kit	FIA45025	EUDAMED	IVD General	Active
Nephstar Apo B Kit	DK042	EUDAMED	IVD General	Active
Kemilo T4 Kit	KM18060	EUDAMED	IVD General	Active
FIA Go PROG Kit	FIA123024	EUDAMED	IVD General	Active
Omlipo SAA Kit	OP52100	EUDAMED	IVD General	Active
Omlipo CRP Kit	OP22200	EUDAMED	IVD General	Active
Omlipo CER Kit	OP18050	EUDAMED	IVD General	Active
GPP-100 ASO Kit	GP21020	EUDAMED	IVD General	Active
Omlipo BMG Kit	OP62050	EUDAMED	IVD General	Active
Multiple Control	SPDM105	EUDAMED	IVD General	Active
FIA Go CK-MB Kit	FIA19025	EUDAMED	IVD General	Active
Nephstar Plus SAA Kit	NP52100	EUDAMED	IVD General	Active
SAA Calibrator	SABZ052	EUDAMED	IVD General	Active
Kemilo hs-cTnI Kit	KM07060	EUDAMED	IVD General	Active
FIA Go TES Kit	FIA47025	EUDAMED	IVD General	Active
Omlipo ALB Kit	OP11050	EUDAMED	IVD General	Active
CER Calibrator	CEBZ018	EUDAMED	IVD General	Active
Solution A	AL00118	EUDAMED	Class A	Active
Kemilo hs-cTnI Kit	KM07018	EUDAMED	IVD General	Active
Kemilo AMH Control	CC032L	EUDAMED	IVD General	Active
GPP-100 Urine TRF Kit	GP68020	EUDAMED	IVD General	Active
Kemilo PROG Control	CC008H	EUDAMED	IVD General	Active
Nephstar C1IN Kit	DK036	EUDAMED	IVD General	Active
Omlipo Urine TRF Kit	OP68050	EUDAMED	IVD General	Active
Omlipo A1M Kit	OP63050	EUDAMED	IVD General	Active
Nephstar bCRP Kit	BK051	EUDAMED	IVD General	Active
Sample Diluent1	DY05655	EUDAMED	Class A	Active
Nephstar AAT Kit	DK038	EUDAMED	IVD General	Active
Specific Protein Analyzer	Nephstar Plus	EUDAMED	Class A	Active
Nephstar IgG Kit	DK004	EUDAMED	IVD General	Active
Nephstar D-Dimer Kit	DK065	EUDAMED	IVD General	Active
Glycated Hemoglobin Analyzer	A1c Go	EUDAMED	Class A	Active
Kemilo AMH Kit	KM32060	EUDAMED	IVD General	Active
Kemilo LH Control	CC027L	EUDAMED	IVD General	Active
Kemilo Cardiac Multiple Control	CC601	EUDAMED	IVD General	Active
FIA Go Myo Kit	FIA09025	EUDAMED	IVD General	Active
Lp(a) Control	DM043	EUDAMED	IVD General	Active
Urine TRF Control	DM068	EUDAMED	IVD General	Active
Kemilo PROG Control	CC008M	EUDAMED	IVD General	Active
lambda-FLC Control Level 2	DM093H	EUDAMED	IVD General	Active

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