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Research and Diagnostic Systems

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BFI002

by Research And Diagnostic Systems, Inc.

Identity

Trade Name
Body Fluid-I EUDAMED
Research and Diagnostic Systems FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
BFA EUDAMED
R & D Body Fluid-I: 6 x 3mL (2 each Level 1,2,3) FDA UDI
Model / Reference
BFI002 EUDAMEDFDA UDI
Description
R & D Body Fluid-I: 6 x 3mL (2 each Level 1,2,3) FDA UDI

Identifiers

Catalog Number
BFI002 FDA UDI
Primary DI / UDI-DI
00815762020087 EUDAMEDFDA UDI
Basic UDI-DI
B-00815762020087 EUDAMED
510(k) Number
K101578 FDA UDI
FDA Product Code
JPK FDA UDI
EMDN Code
W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
GMDN Term
Full blood count IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
864.8625 FDA UDI
Market of Registration
France 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

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 18 Milliliter FDA UDI

Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED

Cleared under the same submission

K101578 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Research And Diagnostic Systems, Inc.

Sources (2)

  • FDA UDI c0d9941e-05f5-4451-9ef9-326b808d8946 38 fields · synced Oct 8, 2026
  • EUDAMED 931e77f6-f021-42ce-9319-6a9bdf2554d7 61 fields · synced Jul 28, 2026