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Research and Diagnostic Systems

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BF002

by Research And Diagnostic Systems, Inc.

Identity

Trade Name
Body Fluid Control EUDAMED
Research and Diagnostic Systems FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
BF EUDAMED
R&D Body Fluid: 4 x 2mL (2 each Level 1,2) FDA UDI
Model / Reference
BF002 EUDAMEDFDA UDI
Description
R&D Body Fluid: 4 x 2mL (2 each Level 1,2) FDA UDI

Identifiers

Catalog Number
BF002 FDA UDI
Primary DI / UDI-DI
00815762020063 EUDAMEDFDA UDI
Basic UDI-DI
B-00815762020063 EUDAMED
510(k) Number
K020229 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 — 8 Milliliter FDA UDI

Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K020229 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Research And Diagnostic Systems, Inc.

Sources (2)

  • FDA UDI 87813e30-b55c-4615-b776-821d9eb325b2 38 fields · synced Oct 6, 2026
  • EUDAMED 3c44af71-d508-465e-8031-38772ffaf0d5 61 fields · synced Jul 24, 2026