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PCA(RS)96 Test(L)

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
PCA(RS)96 Test(L) FDA UDI
Generic Name
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
4096L FDA UDI

Identifiers

Catalog Number
4096L FDA UDI
Primary DI / UDI-DI
00813545022617 FDA UDI
FDA Product Code
DBJ FDA UDI
GMDN Term
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5110 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

Yes

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: Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

PCA(RS)96 Test(L) by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 107f16e2-ef74-4369-8f8c-8c511508a2cf 34 fields · synced May 30, 2026