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Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref SDK60102

by Jiangsu Bioperfectus Technologies Co., Ltd.

Identity

Trade Name
Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column) EUDAMEDFDA UDI
Generic Name
Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name
Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column) EUDAMED
Model / Reference
SDK60102 EUDAMED
50 Tests FDA UDI

Identifiers

Primary DI / UDI-DI
06973342002480 EUDAMEDFDA UDI
Basic UDI-DI
697334200SDK60102APKPL EUDAMED
FDA Product Code
JJH FDA UDI
EMDN Code
W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
GMDN Term
Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
862.2310 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column) by Jiangsu Bioperfectus Technologies Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jiangsu Bioperfectus Technologies Co., Ltd.
EUDAMED SRN
CN-MF-000014691
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED bffdc34f-587c-4edb-8ef5-63f47b2388b1 61 fields · synced Jun 18, 2026
  • FDA UDI 1f964518-c8b5-46b5-8e51-8a05b66f39c7 32 fields · synced May 29, 2026