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Autoimmune EIA

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Autoimmune EIA FDA UDI
Generic Name
Double stranded DNA antibody (anti-dsDNA) IVD, reagent FDA UDI
Device Name
Autoimmune EIA DNA Wash Concentrate, 60 mL FDA UDI
Model / Reference
240DW FDA UDI
Description
Autoimmune EIA DNA Wash Concentrate, 60 mL FDA UDI

Identifiers

Catalog Number
240DW FDA UDI
Primary DI / UDI-DI
00847817007040 FDA UDI
510(k) Number
K960091 FDA UDI
FDA Product Code
LRM FDA UDI
GMDN Term
Double stranded DNA antibody (anti-dsDNA) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 60 Milliliter FDA UDI

Category: Double stranded DNA antibody (anti-dsDNA) IVD, reagent

Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double stranded DNA antibody (anti-dsDNA) IVD, reagent.

Cleared under the same submission

K960091 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 4248be17-736e-472f-a336-256426c57865 38 fields · synced May 31, 2026