PROTEINTECH GROUP INC

FDA Device Registration & Listing · Rosemont, IL, US · Registration 3012214605

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012214605
FEI Number
3012214605
Entity Name
PROTEINTECH GROUP INC
City/State/Country
Rosemont, IL, US
Establishment Address
5500 Pearl St, Suite 400, Rosemont, IL 60018, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Proteintech Group Inc (Owner Number: 10083744)
Owner / Operator Contact Address
5500 Pearl St Suite 400, Rosemont, IL 60018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

p57Kip2 Ab-6 [Clone 57P06; same as KP10] Keratin, HMW Ab-3 (Clone 34?E12) Mouse Monoclonal Antibody Epredia TAG-72 / CA 72-4 (Clone B72.3) Antibody Diluent OP Quanto Lambda Light Chain Ab-2 Rabbit Polyclonal Antibody Negative Control Mouse NY-BR-1 Mouse Monoclonal Antibody Neurofilament (200kDa & 68kDa) Ab-1 (Clone 2F11) Large Volume Phosphate Buffered Saline (25X) Keratin, Pan Ab-1 (Clone AE1/AE3) Mouse Monoclonal Antibody Large Volume Tris Buffered Saline and Tween 20 (20X) c-erbB-2 / HER-2 / neu (Clone EP1045Y) Antibody CD4 Ab-8 (Clone 4B12) Mouse Monoclonal Antibody Tyrosinase AB-1 [Clone T311] UltraVision™ Quanto Detection System HRP DAB CD56 / NCAM-1 Ab-4 [56C04; same as 123A8] CD45 / T200 / LCA Ab-2 (Clone PD7/26/16+2B11) Factor VIII Related Antigen / von Willebrand Factor Ab-1 CA125 (Ovarian Cancer Antigen) Ab-1 (Clone Ov185:1) bcl-2?Ab-1 (Clone 100/D5) Mouse Monoclonal Antibody Keratin 19 Ab-1 (Clone A53-B / A2.26, same as Ks19.1) Vimentin Ab-2 (Clone V9) Mouse Monoclonal Antibody Actin, Smooth Muscle Ab-1 (Clone 1A4; same as asm-1) GLUT-1 Rabbit Polyclonal Antibody CD45RO (T-Cell Marker) Ab-1 (Clone UCHL-1) UltraVision Quanto Detection System HRP DAB PMS2 (Clone EPR3947) Rabbit Monoclonal Antibody Mesothelioma Ab-1 (Clone HBME-1) Mouse Monoclonal Antibody Kappa Light Chain Ab-2 Rabbit Polyclonal Antibody Keratin 18 Ab-1 (Clone DC10) Mouse Monoclonal Antibody p53 Ab-5 (Clone DO-7) Mouse Monoclonal Antibody TTF-1 (Thyroid Transcription Factor-1) Ab-1 (Clone 8G7G3/1) Mucin 5AC (MUC5AC) / Gastric Mucin Ab-1 (Clone 45M1) Keratin 5 Ab-1 (Clone XM26) Mouse Monoclonal Antibody Human Papilloma Virus (HPV) Ab-3 (Clone K1H8) CD68 (Macrophage Marker) Ab-3 (Clone KP1) UltraVision™ Hydrogen Peroxide Block Hepatitis B Virus Surface Antigen Ab-1 ( T9; same as 3E7) Villin Ab-1 (Clone CWWB1) Mouse Monoclonal Antibody Troponin T, Cardiac Isoform Ab-1 (Clone 13-11) CD117 / c-kit Oncoprotein / SCF-Receptor Antibody CD45RA Ab-3 (Clone 4KB5) Mouse Monoclonal Antibody Keratin 5 / 6 Ab-2 (Clone D5/16 B4) CD5 Ab-1 (Clone 4C7) Mouse Monoclonal Antibody Beta-catenin (Clone E247) Rabbit Monoclonal Antibody CD20 Ab-1 (Clone L26) Mouse Monoclonal Antibody Keratin 7 Ab-2 [Clone OV-TL 12/30] Desmin (Muscle Cell Marker) Ab-1 (Clone D33) UltraVision™ Protein Block p504S/ AMACR (Clone 13H4) Rabbit Monoclonal Antibody Citrate Buffer For Heat-Induced Epitope Retrieval GCDFP-15 Gross Cystic Disease Fluid Protein-15 Ab-1 ( 23A3) ALK / p80 Ab-1 (Clone 5A4) Mouse Monoclonal Antibody CD31 / PECAM-1 (Endothelial Cell Marker) Ab-1 ( JC/70A) Hepatocyte Ab-1 (Clone OCH1E5) Mouse Monoclonal Antibody Epredia ERG (Clone 9FY) Mouse Monoclonal Antibody Myeloperoxidase (MPO) Ab-1 Rabbit Polyclonal Antibody EMA Ab-3 (Clone E29) Epredia CD34 (Clone QBEnd/10) Mouse Monoclonal Antibody CD30 (Reed-Sternberg Cell Marker) Ab-1 (Clone Ber-H2) CD68 (Macrophage Marker) Ab-4 (Clone PG-M1) CD10/CALLA (Neutral Endopeptidase) Ab-2 (Clone 56C6) Keratin 5 (Clone EP1601Y) Rabbit Monoclonal Antibody CD44 Std. / HCAM Ab-4 (Clone 156-3C11) PermaFluor™ Aqueous Mounting Medium FITC Protein Blocking Agent (PBA) Epithelial Specific Antigen Ab-9 (Clone Ber-EP4) Glycophorin A Ab-4 (Clone JC159) Mouse Monoclonal Antibody Calponin Ab-1 (Clone CALP) Mouse Monoclonal Antibody Estrogen Receptor Ab-11 (Clone 1D5) CD3? (Clone EP449E) Rabbit Monoclonal Antibody Keratin, Low Molecular Weight Ab-1 (Clone AE1) UltraVision™ Quanto Detection System HRP Keratin 8 / 18 Ab-1 (Clone 5D3)Mouse Monoclonal Antibody CD23 Ab-1 (Clone 1B12) Mouse Monoclonal Antibody CD8 Ab-1 (Clone C8/144B) Mouse Monoclonal Antibody DAB Quanto Pax-5 Rabbit Polyclonal Antibody Perforin Ab-2 (Clone 5B10) Mouse Monoclonal Antibody UltraVision™ Quanto Detection System AP TdT Placental Alk. Phosphatase (PLAP) Ab-4 (Clone 8A9) Melanoma (gp100) Ab-1 (Clone HMB45) Epithelial Specific Antigen / Ep-CAM Ab-1 (Clone VU-1D9) CDX2 (Clone EPR2764Y) Rabbit Monoclonal Antibody CD21 Ab-2 (Clone 2G9) Mouse Monoclonal Antibody CD1a Ab-5 (Clone O10) Mouse Monoclonal Antibody S100 Protein Ab-1 (Clone 4C4.9) Mouse Monoclonal Antibody Keratin 18 (CloneE431-1) Rabbit Monoclonal Antibody CD15 Ab-3 (Clone MMA; Same as LeuM1) Epredia MLH1 (Clone 4C9C7) Mouse Monoclonal Antibody Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 (Clone 26E5) Large Volume Phosphate Buffered Saline and Tween 20 (20X) Keratin 20 Ab-1 (Clone Ks20.8) Mouse Monoclonal Antibody Dog1 (Clone 1.1) Mouse Monoclonal Antibody Napsin A (Clone EPR6252) Rabbit Monoclonal Antibody Large Volume Tris Buffered Saline (25X) E-Cadherin (Clone EP700Y) Rabbit Monoclonal Antibody Factor XIIIA Ab-1 [Clone AC-1A1] Chromogranin A Ab-1 (LK2H10) Mouse Monoclonal Antibody BCL6 (Clone LN22) Mouse Monoclonal Antibody GFAP (Glial Fibrillary Acidic Protein) Ab-6 [Clone ASTRO6] Granzyme B Ab-1 (Clone GZB01) Mouse Monoclonal Antibody Mesothelin Ab-1 (Clone 5B2) Mouse Monoclonal Antibody c-erbB-2 / HER-2 / neu Ab-17 (Clone e2-4001 + 3B5) CD138 Ab-2 (Clone MI15) Mouse Monoclonal Antibody CD2 (LFA-2) Ab-2 (Clone AB75) Mouse Monoclonal Antibody MART-1/Melan-A (Melanoma Marker) Ab-4 [Clone A103]

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor Hematology Class 2 864.1860 2021-12-17
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2023-07-18
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2021-12-17

Official Correspondent

Abdul Issa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Proteintech Group Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0015-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012214605. Last updated year: 2026. Please use registration number 3012214605 when referencing this establishment in official correspondence.
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