← Back to catalogue

"Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)"

EUDAMED

Class IVD General (EU MDR)

Ref R1:60mL×2 R2:20mL×2(701)Ref R1:18mL×4 R2:6mL×4(796)Ref R1:18mL×4 R2:6mL×4(707)Ref R1:48mL×2 R2:16mL×2(715)Ref R1:40mL×3 R2:20mL×2(704)Ref R1:60mL×1 R2:20mL×1(703)Ref R1:18mL×1 R2:6mL×1(702120)Ref R1:60mL×2 R2:20mL×2(706)Ref R1:18mL×4 R2:6mL×4(710)Ref R1:48mL×2 R2:16mL×2(713)Ref R1:48mL×2 R2:16mL×2(716)

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
"Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" EUDAMED
Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method) EUDAMED
Device Name
Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method) EUDAMED
"Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" EUDAMED
Model / Reference
R1:60mL×2 R2:20mL×2(701) EUDAMED
R1:18mL×4 R2:6mL×4(796) EUDAMED
R1:18mL×4 R2:6mL×4(707) EUDAMED
R1:48mL×2 R2:16mL×2(715) EUDAMED
R1:40mL×3 R2:20mL×2(704) EUDAMED
R1:60mL×1 R2:20mL×1(703) EUDAMED
R1:18mL×1 R2:6mL×1(702120) EUDAMED
R1:60mL×2 R2:20mL×2(706) EUDAMED
R1:18mL×4 R2:6mL×4(710) EUDAMED
R1:48mL×2 R2:16mL×2(713) EUDAMED
R1:48mL×2 R2:16mL×2(716) EUDAMED

Identifiers

Primary DI / UDI-DI
06936895300762 EUDAMED
06936895300823 EUDAMED
06936895300816 EUDAMED
06936895300748 EUDAMED
06936895300793 EUDAMED
06936895300663 EUDAMED
06936895300656 EUDAMED
06936895300779 EUDAMED
06936895300830 EUDAMED
06936895300731 EUDAMED
06936895300755 EUDAMED
Basic UDI-DI
B-06936895300762 EUDAMED
B-06936895300823 EUDAMED
B-06936895300816 EUDAMED
B-06936895300748 EUDAMED
B-06936895300793 EUDAMED
B-06936895300663 EUDAMED
B-06936895300656 EUDAMED
B-06936895300779 EUDAMED
B-06936895300830 EUDAMED
B-06936895300731 EUDAMED
B-06936895300755 EUDAMED
EMDN Code
W01010299 SUBSTRATES - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

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

"Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (11)

  • EUDAMED 058e07c6-01a6-4ae3-9bc3-f06c20e7e292 61 fields · synced Oct 6, 2026
  • EUDAMED 5a527ad0-2b25-42fe-a470-35687204a7cd 61 fields · synced May 16, 2026
  • EUDAMED 54c76b99-2286-4603-908f-39a4745d01dd 61 fields · synced May 17, 2026
  • EUDAMED bfdd4fde-3752-46bf-ae56-168d1da6c913 61 fields · synced May 17, 2026
  • EUDAMED 152ddc93-9012-4b43-b2d6-65a492d003a6 61 fields · synced May 17, 2026
  • EUDAMED b727e650-915e-4f43-9379-f34c66a3a27e 61 fields · synced May 18, 2026
  • EUDAMED d5da3384-42e1-4ae4-96be-17aa0a95b339 61 fields · synced May 18, 2026
  • EUDAMED f253b69a-0eaa-4e3c-97f3-cbb506d2a5b5 61 fields · synced May 18, 2026
  • EUDAMED 73d15a0b-4a77-4996-a991-f0bd07c40852 61 fields · synced May 19, 2026
  • EUDAMED b5b8c251-16c3-4290-9fd0-c1f0e9f5cbc6 61 fields · synced May 19, 2026
  • EUDAMED 31a5c46d-7f9a-4bbe-a09c-a89a7e503461 61 fields · synced May 19, 2026