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Satb2 [cl0323]

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
SATB2 [CL0323] FDA UDI
Generic Name
Special AT-rich sequence-binding protein 2 (SATB2) IVD, antibody FDA UDI
Model / Reference
ACI3259B FDA UDI

Identifiers

Primary DI / UDI-DI
00847627028426 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Special AT-rich sequence-binding protein 2 (SATB2) 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

Yes

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

No

FDA UDI

Category: Special AT-rich sequence-binding protein 2 (SATB2) IVD, antibody

Satb2 [cl0323] by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Special AT-rich sequence-binding protein 2 (SATB2) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 801e8fa8-55e6-482e-a089-321d09801782 33 fields · synced Jun 8, 2026