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ihcDirect® Pan-CK 4 Abs-Blk 5mL

FDA UDI

Class I (US FDA UDI)

by Novodiax, Inc.

Identity

Trade Name
ihcDirect® Pan-CK 4 Abs-Blk 5mL FDA UDI
Generic Name
Cytokeratin IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Clones AE1, AE3, C94, R226 FDA UDI
Model / Reference
K46058-005 FDA UDI
Description
Clones AE1, AE3, C94, R226 FDA UDI

Identifiers

Primary DI / UDI-DI
00850030934369 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Cytokeratin IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 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

Yes

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

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

Category: Cytokeratin IVD, kit, enzyme immunohistochemistry

ihcDirect® Pan-CK 4 Abs-Blk 5mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytokeratin IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novodiax, Inc.

Sources (1)

  • FDA UDI 5913f3ea-4424-4264-a19d-c9cd54e70cdc 36 fields · synced May 30, 2026