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Autoscreen I Test System (automated format)

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
Autoscreen I Test System (automated format) FDA UDI
Generic Name
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
1296LA FDA UDI

Identifiers

Catalog Number
1296LA FDA UDI
Primary DI / UDI-DI
00813545022006 FDA UDI
FDA Product Code
DBL FDA UDI
GMDN Term
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 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: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayMitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassaySmooth muscle antibody IVD, kit, fluorescent immunoassayIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

Autoscreen I Test System (automated format) 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 89d95842-5877-4bf7-8242-52069f01a172 34 fields · synced Jun 1, 2026