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Rpr Dispensing Bottle Assembly

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
RPR DISPENSING BOTTLE ASSEMBLY FDA UDI
Generic Name
Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Model / Reference
400-110 FDA UDI

Identifiers

Catalog Number
400-110 FDA UDI
Primary DI / UDI-DI
00813545022570 FDA UDI
FDA Product Code
GMQ FDA UDI
GMDN Term
Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3820 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

No

FDA UDI

Category: Treponema pallidum reagin antibody IVD, kit, agglutination

Rpr Dispensing Bottle Assembly by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum reagin antibody IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 2c5fafe9-0b3d-48d8-92ca-005bd35fcfee 34 fields · synced Jun 8, 2026