← Back to catalogue

Erythrocyte Fragility (osmotic)

FDA UDI

Class I (US FDA UDI)

by BIOANALYTIC GmbH, biomed. Analysentechnik

Identity

Trade Name
Erythrocyte Fragility (osmotic) FDA UDI
Generic Name
Red blood cell count IVD, reagent FDA UDI
Model / Reference
004031-0500 FDA UDI

Identifiers

Primary DI / UDI-DI
04061609000309 FDA UDI
FDA Product Code
JCG FDA UDI
GMDN Term
Red blood cell count IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.8200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Red blood cell count IVD, reagent

Erythrocyte Fragility (osmotic) by BIOANALYTIC GmbH, biomed. Analysentechnik — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Red blood cell count IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
BIOANALYTIC GmbH, biomed. Analysentechnik

Sources (1)

  • FDA UDI efbb4b5e-b317-45b0-a278-789017a6f4f9 32 fields · synced Jun 8, 2026