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ihcDirect® Mart-1 Ab Conjugate 5mL

FDA UDI

Class I (US FDA UDI)

by Novodiax, Inc.

Identity

Trade Name
ihcDirect® Mart-1 Ab Conjugate 5mL FDA UDI
Generic Name
Melan-A/MART-1 peptide IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Clone A103 FDA UDI
Model / Reference
H31009-R005 FDA UDI
Description
Clone A103 FDA UDI

Identifiers

Catalog Number
K46009-005 FDA UDI
Primary DI / UDI-DI
00850000596986 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Melan-A/MART-1 peptide 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

No

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

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 5 Milliliter FDA UDI

Category: Melan-A/MART-1 peptide IVD, kit, enzyme immunohistochemistry

ihcDirect® Mart-1 Ab Conjugate 5mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Melan-A/MART-1 peptide 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 031cd987-b659-4084-90d7-3d04ac45ce3c 37 fields · synced May 30, 2026