Identity
- Trade Name
- Anti-ER (Insite) FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Model / Reference
- AX368-50D FDA UDI
Identifiers
- Catalog Number
- AX368-50D FDA UDI
- Primary DI / UDI-DI
- 00850646007105 FDA UDI
- 510(k) Number
- K013148 FDA UDI
- FDA Product Code
- MYA FDA UDI
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class II 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
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: Estrogen (oestrogen)/progesterone receptor IVD, antibody
Anti-ER (Insite) by Biogenex Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Estrogen (oestrogen)/progesterone receptor IVD, antibody.
- Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 — EPITOMICS, INC. · Class I
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class I
- Progesterone Receptor [PgR636] — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 — Agilent Technologies Inc. · Class II
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class II
- Progesterone Receptor (PR) [16] — BIOCARE MEDICAL, LLC · Class II
Cleared under the same submission
K013148 also covers:
- Anti-ER — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
- Anti-ER (Insite) — Biogenex Laboratories, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 66b3434d-a57c-4ebb-99a5-b4757e027f40 37 fields · synced Jun 1, 2026