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Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody

FDA UDI

Class I (US FDA UDI)

by Cell Marque Corporation

Identity

Trade Name
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody FDA UDI
Generic Name
Coagulation factor XIII A subunit IVD, antibody FDA UDI
Model / Reference
760-4384 FDA UDI

Identifiers

Primary DI / UDI-DI
00841683100805 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Coagulation factor XIII A subunit IVD, antibody 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

Category: Coagulation factor XIII A subunit IVD, antibody

Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor XIII A subunit IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9bebb8ad-d8bf-4309-aa4d-156cd9e711c3 33 fields · synced Jun 8, 2026