Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1831638

FEI Number

1831638

Entity Name

RICHARD-ALLAN SCIENTIFIC LLC

City/State/Country

KALAMAZOO, MI, US

Establishment Address

4481 CAMPUS DR., KALAMAZOO, MI 49008, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Epredia Holdings Ltd. (Owner Number: 10062642)

Owner / Operator Contact Address

20 Post Road, Portsmouth, NH 03801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061360

PMA Number

N/A

All Registered Proprietary Names

Glyo-Fixx Filter Cards, White Filter Cards, Brown Clipped Funnel Starter Kit Cytoclip TPX Sample Chamber Single Cytofunnel, Brown TPX Sample Chamber Closure Caps Double Cytofunnel, White Single Cytofunnel, White Weigert's Iron Hematoxylin Part A Weigert's Iron Hematoxylin Part B MULTIPLE STORAGE CONTAIN SAMCO Clicktainer Specimen Container Nunc Cup SAMCO Sample Cups SAMCO Bio-Tite Specimen Containers SAMCO Specimen Container Urine Transport Containers Nunc Cryogenic Storage Tubes Fisherbrand Sample Cup Capital Vial Multiple Specimen Containers container, specimen, non-sterile - Capital Vial Dry Containers Urine Transport Containers 55 Lugol's Iodine Solution Gram's Iodine Solution iodine, grams - Gram's Iodine Solution 46 Methyl Green-Pyronin Y Stain Solution Basic Fuchsin Stain Solution 38 Basic Fuchsin - Basic Fuchsin Counterstain Embedding Rings Disposable Base Molds Stainless Steel Base Mold Peel-A-Way® EmbeddingMolds Iron Stain Kit; Potassium Ferrocyanide Solution Hydrochloric Acid Solution (20%) Fast Flex Solution 3X Syntri Safeguard Xylene Xylene Clear-Rite 3 Xylene High Purity Syntri Safeguard Xylene Substitute Fast Flex Solution 3C Citrus Clearing Solvent Xylene Substitute Clearant, Syntri Safeguard, Xylene Toluene Clearant, Syntri Safeguard, Clear-Rite 3 Syntri Safeguard Clear-Rite 3 Tissue Marking Dye Red Mark-It Tissue Marking Dye Orange Mark-It Tissue Marking Dye Black Reticulin Silver Stain kit Weigert's Iodine Solution Mark-It Tissue Marking Dye Blue Mark-It Tissue Marking Dye Red Mark-It Tissue Marking Dye Green Mark-It Tissue Marking Dye Kit Tartrazine Stain Solution Tissue Marking Dye Kit Van Gieson Stain Solution Tissue Marking Dye Yellow Potassium Permanganate Solution Silver Nitrate Solution (5%) Silver Nitrate Solution (10%) Silver Nitrate Solution #1 Tissue Marking Dye Green Rapid-Chrome H&E Frozen Section Staining Kit Alcian Blue pH 2.5 Periodic Acid-Schiff Stain Kit Elastic Stain Kit Alcian Blue pH 2.5 Stain Solution Silver Nitrate Solution #2 Tissue Marking Dye Black Mark-It Tissue Marking Dye Yellow Ferric Chloride Solution Tissue Marking Dye Blue Aniline Blue Stain Solution Bouin's Fluid MX35Premier Microtome Blade Microtome Knife, 30CM, C Microtome Knife, 25 CM, D Microtome Knife, 30 CM, D Tungsten Carbide Knife, 16 CM MB35 Premier Microtome Blade MB22 Premier Microtome Blade Microtome Knife, 16 CM, C Tungsten Carbide D-Profile Microtome Knives Microtome Knife, 16 Cm, C Profile Standard Microtome Knife 125 Mm Microtome Knife, 12 CM, D Standard Microtome Knife 250 Mm Microtome Knife, 12 CM, C High-Profile Disposable Blades HP35 Ultra Microtome Blade Microtome Knife D-Profile 160 Mm HP35 Ultra Mictrotome Blade Coated High-Profile Disposable Blades Edge-Rite High-Profile Microtome Blades Stainless-Steel Microtome Knives 12.5 CM Edge-Rite Low-Profile Microtome Blades MX35 Ultra Microtome Blade Microtome Knife D-Profile 240mm Microtome Knife C-Profile 240 Mm MX35 Premier+ Microtome Blade HP35N Ultra Microtome Blade Microtome Knife, 22 CM, D Microtome Knife, 16 CM, D Stainless-Steel Microtome Knives 18.5 CM Amyloid Stain Kit Congo Red Solution Fix-Rite 2 Cytoblock Replacement Reagents Cell-Fixx Cytoblock Kit Cytospin Collection Fluid Histogel Starter Kit Saccomanno Fluid CytoRich Red Mucolexx Papspin Collection Fluid Histogel Ice-It CytoCool II Papspin Specimen Collection Kit Solution, Formol Calcium - AP-9003-125 Citrate Buffer-HIER125mL 10X 66 Modified Grocott's Methenamine Silver (Periodic Acid) Kit 34 methenamine silver - Modified Grocott's Methenamine Silver (Chromic Acid) Kit Reticulocyte Stain Chromic Acid Solution (5%) Nu-Clear II Sodium Thiosulfate Solution (5%) Bluing Reagent (Series R) Phosphotungstic-Phosphomolybdic Acid Solution Nu- Clear I Bluing Reagent Oxalic Acid Solution (1%) GumMastic Solution 1% Acetic Acid Solution Reducing Solution Sodium Bicarbonate Solution Ammonium Hydroxide Solution (28-30%) Sodium Hydroxide Solution (3%) Bluing Reagent (Series S) Tissue Section Adhesive Sensitizing Solution Silver Nitrate Solution (5%) Kwik-Diff Solution 1 May-Grunwald Stain Kwik-Diff Stain Kit Wright-Giemsa Stain Kit Giemsa Stain Wright-Giemsa Stain Buffered Wright-Giemsa Stain Three-Step Stain Solution A Kwik-Diff Solution 2 Kwik-Diff Solution 3 Three-Step Stain Solution B Jenner Stain Modified Wright-Giemsa Stain Pack Three-Step Stain Fixative Rapid-Chrome Kwik-Diff Staining Kit Nerl Hematology Reagents 15 R40079 Gram Safranin safranin - Gram Safranin R40058 Gram Safranin Safranin O Solution 47 Safranin O Stain Solution Gram Safranin R40059 Gram Safranin Hematoxylin Certified Eosin-Y Certified Hydroquinone Capsules Wright Stain Certified Phosphate Buffer pH 7.2 Phosphate Buffer pH 6.6 Instant Hematoxylin Instant Eosin Methenamine-Borax Capsules Mucicarmine Stock Solution Mucicarmine Stain Kit Periodic Acid Solution (1%) Periodic Acid Solution Periodic Acid Solution (0.5%) Buffered Wright Stain Modified Wright Stain Pack Wright Stain Gram Crystal Violet Solution Crystal Violet Solution Cryochrome Blue Cryochrome Sampler MB22 Premier Microtome Blade Neg 50 Blue Cryomatrix Neg 50 Green Neg 50 Pink Neg 50 Yellow Colorless Neg-50 Water Soluble Frozen Section Medium Neg 50 Colorless Neg 50 Orange Cryochrome Green Neg-50 Water Soluble Frozen Section Medium M-1 Embedding Matrix Cryochrome Pink Cryochrome Yellow Acid Fast Bacillus Stain (Blue Secondary Stain) Shandon Acid-Fast Bacillus Stain Modified Grocott's Methenamine Silver StainKit (Chromic Acid) Gram Stain Kit - Tissue;Modified Grocott's Methenamine Silver Stain Kit Gram Stain Kit - Film Modified Steiner-Steiner Silver Stain Kit Gram Stain Kit Acid Fast Bacillus Stain(Green Secondary Stain) van gieson's stain - VAN GIESON'S STAIN 42 Harris Hematoxylin Non-acidified (Series S) Harris Hematoxylin Acidified Modified Harris Hematoxylin (Series R) Harris Hematoxylin Acidified (Series S) Histofix Safe Fix 22 CD4 [4B12] 0.1ml (Culture Sup.) Desmin [D33] 0.5ml (Culture Sup.) MART-1 / Melan-A [A103] 7mL Keratin 5 1ml (Culture Sup.) CD68 [KP1] 0.5mL CDw75 [LN1] 0.1mL Factor VIII/von Willebrand 1mL Calcitonin [SP17] 0.5mL Calponin [CALP] 1mL p57 Kip2 1mL Calponin [CALP] 0.1mL Troponin T, Cardiac Isoform 0.5mL CD3 (Early T Cell Marker) 1mL CD68 [KP1] 1mL Keratin 20 [Ks20.8] 7ml RTU Epithelial Membrane Ant. 1mL Large Vol Tris Buffer Saline and Tween 20 (20X) 125ml PSA [EP1588Y] 1ml (Culture Sup.) Myeloperoxidase (MPO) 0.5mL Ep-CAM [Ber-EP4] 1ml (Culture Sup.) Keratin 8 [EP1628Y] 1ml (Culture Sup.) Chromogranin A [SP12] 1mL Immunoglobulin M (IgM) 2mL GFAP [ASTR06] 7mL CD10/CALLA [56C6] 0.5ml (Culture Sup.) Antibody Diluent OP Quanto 125ml MAP 2a,b,c [AP18] 0.5mL CD68 / Macrophage Marker 7ml RTU S100 Protein [4C4.9] 1mL UltraVision Protein Block60ml PR [hPRa 2+hPR 3] 12mL CD45 / T200 / LCA 0.1mL ZAP-70 [2F3.2] 0.5mL CDX2 [EPR2764Y] 7ml RTU ACTH [AH26] 0.5mL Factor VIII Related Antigen 0.5mL p504S/ AMACR [13H4] 12ml RTU Hepatocyte [OCH1E5] 1ml (Culture Sup.) CD15 0.5mL CD68 / Macrophage Marker 1ml (Culture Sup.) Ep-CAM [Ber-EP4] 0.5ml (Culture Sup.) Melanoma (gp100) [HMB45] 0.1ml (Culture Sup.) CD3epsilon 12ml RTU Keratin 19 1mL Keratin 20 [Ks20.8] 0.1ml (Culture Sup.) HPV [K1H8] 0.1ml (Culture Sup.) CD117 /c-Kit /SCF-Receptor 0.5mL p53 1mL Synaptophysin 12mL CD43 /T-Cell Marker [DF-T1] 0.5mL p57 Kip2 0.1mL ER (Cocktail) [1D5+6F11] 7mL (HBVsAg) 7ml RTU Mesothelin [5B2] 0.5mL (Culture Sup.) c-erbB-2 /HER-2 /neu [SP3] 0.5mL Epstein-Barr Virus / LMP 0.5ml (Culture Sup.) Keratin 18 [DC10] 0.5mL TTF-1 [8G7G3/1] 12mL CDX2 [EPR2764Y] 0.1ml (Culture Sup.) E-Cadherin 0.1ml (Culture Sup.) Desmin [D33] 1ml (Culture Sup.) Pepsin Solution for Enzyme-Induced Epitope Retrieval 5ml Catenin, beta 0.5mL GCDFP-15 [23A3] 1ml (Culture Sup.) CD1a [O10] 0.5mL MAC L1 Protein /Calprotec 1mL UltraVision Quanto DetectionSystem HRP 125ml CD4 [4B12] 1ml (Culture Sup.) (HBVsAg) 0.1ml (Culture Sup.) Tyrosinase [T311] 12mL CD57 [NK1] 0.5mL HPV [K1H8] 7ml RTU UltraVision Quanto HRP DAB 15ml Keratin 10 [DE-K10] 0.5mL CD117 /c-Kit /SCF-Receptor 1mL E-Cadherin 7ml RTU ACTH [AH26] 7mL GLUT-1 0.5mL p57 Kip2 0.5mL Caldesmon, HMW 0.5mL CD74 [LN2] 1mL Keratin 7 12mL CD99 / MIC2 [H036-1.1] 0.1mL Tubulin-Beta 1mL MART-1 / Melan-A [A103] 1mL CD10/CALLA [56C6] 12ml RTU EGFR [EP38Y] 7ml RTU c-erbB-2 /HER-2 /neu [SP3] 12mL CD30 (Reed-Sternberg CM) 7ml RTU CD5 [4C7] 12ml RTU Helicobacter pylori 7mL DOG-1 [1.1] 7ml RTU p53 0.5mL c-erbB-2 / HER-2 / neu 0.5mL Troponin T, Cardiac Isoform 1mL Perforin [5B10] 0.1ml (Culture Sup.) CD2 (LFA-2) [AB75] 1ml (Culture Sup.) p53 [SP5] 0.5mL CD5 [SP19] 0.1mL UltraVision Hydrogen Peroxide Block125ml Lambda Light Chain 1mL Epstein-Barr Virus / LMP 7ml RTU Myeloperoxidase (MPO) 1mL CD3 (Early T Cell Marker) 0.5mL Desmin 7mL CD43 /T-Cell Marker [DF-T1] 1mL EGFR [EP38Y] 1ml (Culture Sup.) Keratin 20 [Ks200.8] 0.5mL TdT [SEN28] 0.5ml (Culture Sup.) PLAP [8A9] 0.5ml (Culture Sup.) CD23 [SP23] 1mL Hier Buffer M MAP 2a,b,c [AP18] 1mL Neurofilament [2F11] 0.1ml (Culture Sup.) UltraVision ONE Detection System HRP Polymer (Ready-to-use) 125ml Chromogranin A [LK2H10] 1mL Caldesmon, HMW 1mL CD4 [4B12] 7ml RTU Myeloperoxidase (MPO) 12ml RTU CD74 [LN2] 0.5mL CD79a / mb-1 [SP18] 0.1mL TTF-1 [8G7G3/1] 0.5mL Keratin, HMW [34BetaE12] 0.5ml (Culture Sup.) Cyclin D1 / Bcl-1 [SP4] 0.5mL CA19-9 / Sialyl Lewis a 0.5mL FITC Protein Blocking Agent (PBA) 6ml Mesothelioma [HMBE-1] 1ml (Culture Sup.) p53 [DO-7] 1mL Keratin, Pan [AE1/AE3] 7mL Protein Gene Product 9.5 0.5mL Ki-67 [SP6] 7mL CD68 [KP1] 7mL EGFR [EP38Y] 12ml RTU CD20 [L26] 7ml RTU (HBVsAg) 12ml RTU MART-1 / Melan-A [A103] 12mL TAG-72 / CA 72-4 [B72.3] 1mL Chromogranin A [LK2H10] 0.5mL CD45 / T200 / LCA 12mL UltraVision LP HRP Polymer & DAB Plus Chromogen 125ml PR [hPRa 2+hPR 3] 1mL CD20 0.1mL Properdin FITC Lab 2mL Villin [CWWB1] 1mL p53 [SP5] 0.1mL CD31 / PECAM-1 [JC/70A] 1mL CD4 [4B12] 12ml RTU Lambda Light Chain 0.5mL Insulin [INS04 + INS05] 0.5mL CD45RO (T-Cell Marker) 5 slides UltraVision LP Large Vol HRP Polymer 1000ml UltraVision LP HRP Polymer & DAB Plus Chromogen 15ml Protease XXV for Enzyme-Induced Epitope Retrieval 5ml Vimentin [V9] 1mL GFAP [ASTR06] PCS 5 slides p53 0.1mL CA 125 (Ovarian Cancer Ant) 1ml (Culture Sup.) CD3epsilon (Early T-Cell M) 7ml RTU GCDFP-15 [23A3] 7ml RTU Keratin 18 [DC10] 1mL CD5 [4C7] 7ml RTU CD57 [NK1] 7mL Kappa Light Chain [L1C1] 1mL ER (Cocktail) [1D5+6F11] 0.1mL BCL-2alpha [100/D5] 0.5mL Keratin, HMW [34BetaE12] 7ml RTU Factor XIII A 0.5mL CD5 [SP19] 1mL CD68 / Macrophage Marker 0.5ml (Culture Sup.) Desmin [D33] 7ml RTU CA19-9 / Sialyl Lewis a 1mL CD8 [C8/144B] 0.5mL PSA [EP1588Y] 12ml RTU Perforin [5B10] 0.5ml (Culture Sup.) Placental Lactogen (hPL) 0.5mL Serotonin [5HT-H209] 0.5ml (Culture Sup.) p504S/ AMACR [13H4] 0.5mL PMS2 [EPR3947] 7ml RTU CD8 [SP16] 1mL CD30 (Reed-Sternberg CM) 0.5ml (Culture Sup.) CD44 Std. / HCAM 1mL ALK / p80 [5A4] 0.1ml (Culture Sup.) Keratin 8 / 18 [5D3] 12ml RTU Keratin 20 [Ks20.8] 12ml RTU Estrogen Receptor [1D5] 1mL Keratin 8 / 18 [5D3] 0.1ml (Culture Sup.) Epstein-Barr Virus / LMP 1ml (Culture Sup.) Calponin [CALP] 0.5mL DAB Quanto 60ml CD56 / NCAM-1 1mL PermaFluor Aqueous Mounting Medium 30ml BCL-2alpha [100/D5] 1mL TAG-72 / CA 72-4 [B72.3] 12mL CD117 /c-Kit /SCF-Receptor 12mL Renal Cell Carcinoma Mark. 7mL p504S/ AMACR [13H4] 7ml RTU Actin, Smooth Muscle [1A4] 12mL CD45 / T200 / LCA 1mL CD45RB [PD7/26] 0.5mL Kappa Light Chain 1mL Mucin 2 (MUC-2) [M53] 0.1mL Claudin 4 0.5mL Keratin 8 / 18 [5D3] 7ml RTU Keratin 8 / 18 [5D3] 1ml (Culture Sup.) Citrate Buffer for HIER 500ml Keratin 5 / 6 1ml (Culture Sup.) PLAP [8A9] 1ml (Culture Sup.) MLH1 [4C9C7] 7ml RTU BCL-2alpha [100/D5] 7mL CD8 [C8/144B] 7mL CD56 / NCAM-1 7ml RTU UltraVision Quanto HRP DAB 1000ml CD23 [SP23] 7mL IgD (delta-Heavy Chain) 0.1mL Tris-HCl Buffer for HIER (10X) 50ml CD3 (Early T Cell Marker) 0.1mL CD20 [L26] 0.1ml (Culture Sup.) Vimentin-gp100 7mL Keratin, Pan [AE1/AE3] 1mL Large Vol Tris Buffered Saline (25X) 125ml CD23 [SP23] 0.5ml (Culture Sup.) Keratin 5 / 6 0.5ml (Culture Sup.) Calretinin [SP13] 1mL Citrate Buffer for HIER 125ml CD8 [C8/144B] 1mL Synaptophysin 0.5mL Keratin, Pan [AE1/AE3] 12mL Hier Buffer H TTF-1 [8G7G3/1] 1mL Phosphate Buffered Saline (10X) UltraVision Quanto HRP DAB 125ml CD3-CD20 7mL CD99 / MIC2 [H036-1.1] 1mL Renal Cell Carcinoma Mark. 1mL Granzyme B [GZB01] 0.5mL Actin, Smooth Muscle [1A4] 1mL CD34 [QBEnd/10] 0.1mL (VEGF) 0.5mL c-erbB2 / HER-2 / neu 12ml RTU PSAP [PASE/4LJ] 0.5mL Renal Cell Carcinoma Mark. 0.5mL CD1a [O10] 1mL Desmin [D33] 12ml RTU NY-BR-1 1mL (HBVsAg) 1mL p21 WAF1 [DCS-60.2] 0.1mL Keratin, Pan [AE1/AE3] 0.5mL CD99 / MIC2 [H036-1.1] 7mL c-erbB-2 /HER-2 /neu [SP3] 0.1mL Tubulin-Beta 0.5mL Cyclin D1 / Bcl-1 [SP4] 12mL ERG [9FY] 1mL CD8 [SP16] 7mL DAB Quanto 1000ml p504S/ AMACR [13H4] 1mL MultiVision CD3 epsilon 7ml RTU ACTH [AH26] 1mL Kappa Light Chain 0.5mL Large Vol Phosphate Buffered Saline (25X) 125ml Vimentin [V9] 0.5mL Actin, Muscle Specific 0.5ml (Culture Sup.) EDTA Buffer for HIER (10X) 500ml Myeloperoxidase (MPO) 0.1mL Cyclin D1 / Bcl-1 [SP4] 7mL CD23 [1B12] 0.5ml (Culture Sup.) Vimentin [V9] 12mL UltraVision Protein Block 1000ml CD30 (Reed-Sternberg CM) 1ml (Culture Sup.) Tris-HCl Buffer for HIER (10X) 125ml UltraVision Quanto HRP DAB 60ml UltraVision LP Large Vol HRP Polymer (RTU) 60ml Chromogranin A [SP12] 0.1mL Helicobacter pylori 12mL Desmin 0.5mL ER (Cocktail) [1D5+6F11] 1mL UltraVision Hydrogen Peroxide Block60ml CD68 [KP1] 12mL c-erbB-2 /HER-2 /neu [SP3] 1mL CD1a [O10] 12mL Lysozyme / Muramidase 0.5mL HPV [K1H8] 1ml (Culture Sup.) Hepatocyte [OCH1E5] 0.1ml (Culture Sup.) Keratin, LMW [AE1] 0.1mL Glycophorin A [JC159] 7mL DOG-1 [1.1] 0.1mL CD34 [QBEnd/10] 1mL Calretinin 0.5mL Epithelial Membrane Ant. 12ml RTU Renal Cell Carcinoma Mark. 12mL p53 [DO-7] 0.5mL Tyrosinase [T311] 1mL Helicobacter pylori 1mL UltraVision Protein Blk 125ml Melanoma (gp100) [HMB45] 7ml RTU Keratin, HMW [34BetaE12] 1ml (Culture Sup.) DOG-1 [1.1] 1mL CD5 [4C7] 1ml (Culture Sup.) Keratin 5 / 6 7ml RTU CD20 [L26] 12ml RTU Ep-CAM [VU-1D9] 0.5mL CD4-CD8 7mL Ki-67 [SP6] 12mL GFAP [ASTR06] 0.5mL CD79a / mb-1 [SP18] 1mL Keratin 8 [TS1] 0.5mL CD34 [QBEnd/10] 7ml RTU Factor XIII A 7mL CD21 [2G9] 1ml (Culture Sup.) Keratin 19 7mL CDX2 [EPR2764Y] 12ml RTU Actin, Muscle Specific 1ml (Culture Sup.) CD15 7mL Actin, Muscle Specific 7ml RTU CD15 12mL Synaptophysin 7mL MART-1 / Melan-A [A103] 0.1mL UltraVision Quanto DetectionSystem HRP 1000ml CD8 0.5mL BCL-6 [LN22] 1ml (Culture Sup.) Keratin 8 [TS1] 1mL Napsin-A [EPR6252] 12ml RTU MAC L1 Protein /Calprotec 0.5mL Keratin 17 [E3] 0.5mL CD30 (Reed-Sternberg CM) 12ml RTU ER (Cocktail) [1D5+6F11] 0.5mL CD5 [SP19] 7mL HIER Buffer H Tyrosinase [T311] 0.5mL GFAP [ASTR06] 1mL Pax-5 [SP34] 1mL Pax-5 [SP34] 12mL CD20 7mL S100 Protein [4C4.9] 0.5mL Desmin [D33] 0.1ml (Culture Sup.) Keratin 18 [DC10] 7mL CD3 (Early T Cell Marker) 7mL UltraVision Quanto DetectionSystem HRP 60ml Keratin 5 12ml RTU Keratin 8 / 18 [5D3] 0.5ml (Culture Sup.) EDTA Buffer for HIER (10X) 125ml MAP 2a,b,c [AP18] 7mL CD5 [4C7] 0.5mL Tubulin-Alpha 0.5mL Epithelial Membrane Ant. 7mL Keratin 5 [XM26] 0.5ml (Culture Sup.) Glycophorin A [JC159] 0.5mL PermaFluor Aqueous Mounting Medium 6ml Caldesmon, HMW 7ml RTU Gastrin 0.5mL CD10/CALLA [56C6] 7ml RTU c-erbB-2 /HER-2 /neu [SP3] 7mL CA 125 (Ovarian Cancer Ant) 7ml RTU MUC-5AC /Gastric Mucin 0.5mL CDw75 [LN1] 0.5mL Desmin 0.1mL CD4 [4B12] 0.5mL (Culture Sup.) Neurofilament [2F11] 0.5mL Cyclin D1 / Bcl-1 [SP4] 0.1mL Perforin [5B10] 7ml RTU CD8 [C8/144B] 0.1mL Hier Buffer L Epithelial Membrane Ant. 0.5mL UltraVision LP HRP Polymer & DAB Plus Chromogen 60ml MART-1 / Melan-A [A103] 0.5mL PSAP [PASE/4LJ] 1mL Calretinin [SP13] 0.1mL CD44 Std. / HCAM 0.5mL Factor XIII A 1mL CD57 [NK1] 1mL CD45RO (T-Cell Marker) 0.5mL CD45 / T200 / LCA 7mL Neurofilament [2F11] 7ml RTU CD15 0.1mL p504S/ AMACR [13H4] 0.1mL CD10/CALLA [56C6] 0.1ml (Culture Sup.) E-Cadherin 1ml (Culture Sup.) Large Vol Phosphate Buffered Saline and Tween 20 (20X) 125ml CD5 [SP19] 0.5mL CA19-9 / Sialyl Lewis a 7mL p53 [SP5] 7mL CD20 [L26] 1ml (Culture Sup.) CD68 / Macrophage Marker 0.1ml (Culture Sup.) Keratin 7 1mL Chromogranin A [SP12] 0.5mL Tris Buffer Saline and Tween 20 Large Vol (20X)1000ml CD21 [2G9] 0.5ml (Culture Sup.) Synaptophysin 0.1mL CA 125 (Ovarian Cancer Ant) 0.5ml (Culture Sup.) CD3epsilon (Early T-Cell M) 0.5mL Renal Cell Carcinoma Mark. 0.1mL E-Cadherin 12ml RTU Calcitonin [SP17] 1mL CD5 [SP19] 12mL Keratin, LMW [AE1] 7mL CD23 [1B12] 1ml (Culture Sup.) p21 WAF1 [DCS-60.2] 7mL PSA [EP1588Y] 0.1ml (Culture Sup.) Hepatocyte [OCH1E5] 0.5ml (Culture Sup.) MUC-5AC /Gastric Mucin 1mL Calretinin [SP13] 0.5mL CD30 (Reed-Sternberg CM) 0.1ml (Culture Sup.) S100 Protein [4C4.9] 12mL Keratin, HMW [34BetaE12] 12ml RTU Melanoma (gp100) [HMB45] 12ml RTU Factor VIII/von Willebrand 0.5mL CD21 [2G9] 7ml RTU Dewax and HIER Buffer Variety Pack CD21 [2G9] 0.1ml (Culture Sup.) CD45RA [4KB5] 0.5mL CD23 [1B12] 12ml RTU BCL-2alpha [100/D5] 12mL UltraVision LP Large Vol HRP Polymer (RTU) 125ml CD30 (Reed-Sternberg CM) 0.5mL CD1a [O10] 0.1mL CD8 [SP16] 0.5mL CD2 (LFA-2) [AB75] 0.5ml (Culture Sup.) (PSMA) [SP29] 1mL Ep-CAM [Ber-EP4] 7ml RTU HPV [K1H8] 0.5ml (Culture Sup.) UltraVision LP Large Vol AP Polymer (Ready-to-use) 60ml Keratin 7 0.5mL CD45 / T200 / LCA 0.5mL p53 [SP5] 1mL Keratin 5 [XM26] 7ml RTU CD30 (Reed-Sternberg CM) 1mL Dystrophin 0.5mL Chromogranin A [SP12] 7mL Beta-catenin 12ml RTU CD99 / MIC2 [H036-1.1] 0.5mL CD15 1mL Keratin 8 [TS1] 7mL GLUT-1 1mL Ep-CAM [Ber-EP4] 0.1ml (Culture Sup.) UltraVision LP Large Vol AP Polymer (Ready-to-use) 125ml Ki-67 [SP6] 0.5mL Calretinin [SP13] 12mL Lambda Light Chain 7mL CD10/CALLA [56C6] 1ml (Culture Sup.) Pax-5 1mL GCDFP-15 [23A3] 12ml RTU Keratin 18 1ml (Culture Sup.) Keratin, LMW [AE1] 0.5mL Claudin 3 0.5mL GCDFP-15 [23A3] 0.5mL (Culture Sup.) Melanoma (gp100) [HMB45] 1ml (Culture Sup.) Granulocyte Ab-1 [BM-2] 0.1mL Keratin 20 [Ks20.8] 1ml (Culture Sup.) MAP 2a,b,c [AP18] 0.1mL Beta-catenin 1ml (Culture Sup.) Phosphate Buffered Saline andTween 20 Large Vol (20X)1000ml Tris-HCl Buffer for HIER (10X) 500ml Calponin [CALP] 7ml RTU Mesothelioma [HMBE-1] 7ml RTU Kappa-Lambda 7mL Keratin, HMW [AE3] 7mL p53 [DO-7] 12mL CD20 1mL CD79a / mb-1 [SP18] 0.5mL Actin, Smooth Muscle [1A4] 7mL Synaptophysin 1mL CD34 [QBEnd/10] 12ml RTU c-erbB-2 / HER-2 / neu 0.1mL GFAP [ASTR06] 0.1mL HPV [K1H8] 1mL Mucin 2 (MUC-2) [M53] 0.5mL Cyclin D1 / Bcl-1 [SP4] 1mL Hepatocyte [OCH1E5] 7ml RTU CD2 (LFA-2) [AB75] 7ml RTU Ki-67 [SP6] 0.1mL Keratin, LMW [AE1] 1mL Mesothelin [5B2] 1ml (Culture Sup.) Keratin, HMW [34BetaE12] 0.1ml (Culture Sup.) CD79a / mb-1 [SP18] 7mL CD3epsilon (Early T-Cell M) 1mL Helicobacter pylori 0.5mL Keratin 8 [EP1628Y] 7ml RTU Caldesmon, HMW 0.1mL Actin, Smooth Muscle [1A4] 0.5mL Kappa Light Chain [L1C1] 7mL Protease XXV for Enzyme-Induced Epitope Retrieval 2ml Albumin, FITC Label 2mL Perforin [5B10] 1ml (Culture Sup.) CDX2 [EPR2764Y] 1ml (Culture Sup.) GCDFP-15 [23A3] 0.1ml (Culture Sup.) ALK / p80 [5A4] 1ml (Culture Sup.) Glypican-3 [1.1] 7ml RTU PSA [EP1588Y] 7ml RTU CD31 / PECAM-1 [JC/70A] 0.5ml Epithelial Membrane Ant. 0.1mL Chromogranin A [SP12] 12mL IgD (delta-Heavy Chain) 0.5mL CD21 [2G9] 12ml RTU Factor VIII Related Antigen 1mL Glycophorin A [JC159] 1mL c-erbB2 / HER-2 / neu 1ml (Culture Sup.) Keratin 19 0.5mL Villin [CWWB1] 0.5mL Myeloperoxidase (MPO) 7ml RTU CD56 / NCAM-1 0.5mL c-erbB-2 / HER-2 / neu 1mL Melanoma (gp100) [HMB45] 0.5ml (Culture Sup.) CD31 / PECAM-1 [JC/70A] 12mL Lambda Light Chain 1mL p53 [Y5] 1ml (Culture Sup.) CD20 [L26] 0.5mL Ki-67 [SP6] 1mL Granzyme B [GZB01] 1ml (Culture Sup.) Mesothelioma [HMBE-1] 0.5ml (Culture Sup.) CD117 /c-Kit /SCF-Receptor 0.1mL Dewax and HIER Buffer L CD3 (Early T Cell Marker) 12mL CD20 0.5mL Keratin 5 / 6 0.1ml (Culture Sup.) OCT3/4 (POU5F1) [653108] 0.1mL Dewax and HIER Buffer M (HBVsAg) 0.5ml (Culture Sup.) Kappa Light Chain [L1C1] 0.5mL HIER Buffer M Placental Lactogen (hPL) 1mL CD3epsilon 1ml (Culture Sup.) CD117 /c-Kit /SCF-Receptor 7mL Keratin 5 / 6 12ml RTU Keratin, HMW [AE3] 0.5mL p57 Kip2 7mL p57 Kip2 [KP39] 0.5mL CD1a [O10] 7ml RTU HIER Buffer L Epredia Carbol Fuchsin Solution Three-Step Stain Set ClearVue Mountant TA-006-FM PermaFluor Aqueous Mounting Medium 6ml Cytoseal 280 Immu-Mount TA-125-AM SI Prep, Aqua-Mount 125ml EZ-Mount Cytoseal XYL ClearVue Mountant XYL Shandon-Mount Consul-Mount Aqua-Mount Synthetic Mountant Mounting Medium Cytoseal 60 Xylene Substitute Mountant TA-030-FM PermaFluor Aqueous Mounting Medium 30ml Schiff Reagent Periodic Acid-Schiff Stain Kit TBD-2 Decalcifier Cal-Rite TBD-1 RapidDecalcifier Decalcifiying Solution Laser biopsy cassettes in stripped stacks (aqua) 25x40 with hinged lid Bionet cassettes in stripped stacks (ochre) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (green) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (ochre) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (yellow) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (white) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (ochre) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (beige) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 45x40 without lid (require metal lid) Epredia PrintMate Slotted Cassette Epredia Tissue Cassette I Epredia Embedding Rings Epredia PrintMate Biopsy Cassette Epredia Tissue Capsule pads Epredia Cassette 2 Slotted Laser biopsy cassettes in stripped stacks (red) 25x40 with front lid Laser biopsy cassettes in stripped stacks (ochre) 25x40 with front lid Epredia Cassette II Tissue Laser biopsy cassettes in stripped stacks (red) 25x40 with hinged lid Bionet cassettes in stripped stacks (beige) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (lilac) 45x40 without lid (require metal lid) Bionet cassettes in stripped stacks (blue) 25x40 with front lid Tissue Cassette Embedded Lid Laser embedding cassettes in stripped stacks (aqua) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (blue) 25x40 with front lid Epredia Embedding Cassettes without Lids Laser embedding cassettes in stripped stacks (grey) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (orange) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (white) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 25x40 with front lid Laser embedding cassettes in stripped stacks (yellow) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (pink) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (yellow) 45x40 with integrated lid Epredia Thinline Slotted Cassette Laser biopsy cassettes in stripped stacks (aqua) 25x40 with front lid Laser biopsy cassettes in stripped stacks (yellow) 25x40 with front lid Laser embedding cassettes in stripped stacks (ochre) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 25x40 with front lid Laser embedding cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (orange) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (green) 25x40 with front lid Laser embedding cassettes in stripped stacks (blue) 45x40 with integrated lid Epredia Fine Pore Cassette Laser biopsy cassettes in stripped stacks (yellow) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (blue) 25x40 with hinged lid Bionet cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (grey) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (grey) 45x40 with integrated lid Bionet cassettes in stripped stacks (white) 25x40 with front lid Bionet cassettes in stripped stacks (green) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 45x40 with integrated lid Epredia Biopsy Cassette I Laser biopsy cassettes in stripped stacks (orange) 25x40 with front lid Laser biopsy cassettes in stripped stacks (grey) 25x40 with front lid Laser biopsy cassettes in stripped stacks (white) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (white) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (lilac) 25x40 with hinged lid Bionet cassettes in stripped stacks (orange) 25x40 with front lid Fa-Tech Biopsy Cassettes Laser embedding cassettes in stripped stacks (white) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (lilac) 45x40 with integrated lid Bionet cassettes in stripped stacks (aqua) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 25x40 with hinged lid Bionet cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (beige) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (beige) 25x40 with front lid Bionet cassettes in stripped stacks (grey) 25x40 with front lid Bionet cassettes in stripped stacks (yellow) 25x40 with front lid Laser embedding cassettes in stripped stacks (yellow) 25x40 with front lid Laser biopsy cassettes in stripped stacks (white) 25x40 with front lid Laser embedding cassettes in stripped stacks (orange) 45x40 with integrated lid Fa-Tech Embedding Cassettes Laser biopsy cassettes in stripped stacks (blue) 25x40 with hinged lid Epredia HistoScreen Cassette Laser embedding cassettes in stripped stacks (red) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (lilac) 25x40 with hinged lid Epredia Metal Lids Epredia PrintMate Embedding Cassette Laser embedding cassettes in stripped stacks (orange) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (beige) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (beige) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (blue) 45x40 without lid (require metal lid) Bionet cassettes in stripped stacks (red) 25x40 with front lid Laser embedding cassettes in stripped stacks (blue) 25x40 with front lid Epredia TissueLoc Slotted Cassette Laser embedding cassettes in stripped stacks (beige) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (ochre) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (orange) 25x40 with front lid Laser embedding cassettes in stripped stacks (grey) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (pink) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (grey) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (green) 25x40 with front lid Laser biopsy cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (ochre) 25x40 with hinged lid Eosin-Y Alcoholic (Series R) Eosin-Y Saturated (Series R) Eosin-Y Eosin Aqueous Eosin-Y Alcoholic Eosin Y Aqueous (Series S) Eosin-Y with Phloxine (Series R) Eosin-Y Alcoholic (Series S) Instant Eosin Aqueous (Series S) Instant Eosin Alcoholic (Series S) RabMAb Anti-PR 70 Gomori's Trichrome Stain Blue Collagen Gomori's Trichrome Stain Kit Green Collagen Gomori's Trichrome Stain Kit Blue Collagen Gomori's Trichrome Stain Green Collagen Masson Trichrome Stain Kit RabMAb Anti-ER 69

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IFL	Polyethylene Glycol Preservative	Pathology	Class 1	864.4010	2020-03-09
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2020-03-12
IAE	Hematoxylin, Iron, Weigert'S	Hematology	Class 1	864.1850	2020-03-09
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-03-12
HYI	Iodine, Grams	Hematology	Class 1	864.1850	2020-03-09
HZA	Methyl Green	Hematology	Class 1	864.1850	2020-03-09
KKW	Basic Fuchsin	Hematology	Class 1	864.1850	2020-03-09
KER	Container, Embedding	Pathology	Class 1	864.3010	2020-02-28
GGH	Iron Stains	Hematology	Class 1	864.1850	2020-03-09
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2020-03-12
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2020-03-10
KFD	Aniline Blue	Hematology	Class 1	864.1850	2020-03-09
IGN	Fluid, Bouin'S	Pathology	Class 1	864.4010	2020-03-10
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2020-03-12
ICH	Congo Red	Hematology	Class 1	864.1850	2020-03-09
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2020-03-10
IGD	Solution, Formol Calcium	Pathology	Class 1	864.4010	2020-03-12
HYZ	Methenamine Silver	Hematology	Class 1	864.1850	2020-03-09
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	2020-03-09
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2020-03-12
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2020-03-10
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2020-02-28
HZS	Safranin	Hematology	Class 1	864.1850	2020-03-09
LEF	Stains, Dye Powder	Hematology	Class 1	864.1850	2020-03-12
HZC	Mucicarmine	Hematology	Class 1	864.1850	2020-03-09
KKS	Acid, Periodic	Hematology	Class 1	864.1850	2020-03-10
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2020-03-12
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2020-03-09
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	2020-03-12
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2020-03-10
IAC	Van Gieson'S Stain	Hematology	Class 1	864.1850	2020-03-09
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2020-03-09
LDW	Fixative, Acid Containing	Pathology	Class 1	864.4010	2020-03-09
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2020-03-12
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2020-03-10
LEB	Mounting Media	Pathology	Class 1	864.4010	2020-03-12
HZT	Reagent, Schiff	Hematology	Class 1	864.1850	2020-03-09
KDX	Solution, Decalcifier, Acid Containing	Pathology	Class 1	864.4010	2020-03-10
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2020-02-28
HYB	Eosin Y	Hematology	Class 1	864.1850	2020-03-12
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Hematology	Class 2	864.1860	2020-02-25
HYW	Stain, Trichrome, Mallory'S	Hematology	Class 1	864.1850	2020-03-10
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	Class 2	864.1860	2020-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Epredia Holdings Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011631044	FA-Tech Diagnostics Europe BV	Duiven Gelderland, NL
1219230	NEW ERIE SCIENTIFIC LLC	Portsmouth, NH, US
3005642384	Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd	SHANGHAI, CN
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03
K821443	Lerner Laboratories, Inc.	FORMICAL	1982-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2015	Richard-Allan Scientific Company	1	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0014-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0015-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0016-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0017-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0018-2015	Richard-Allan Scientific Company	1	Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

Similar Registrations

Registration Number	Establishment Name	Location
1640981	SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, US
3010461097	Wuhan Landing Intelligence Medical Co.,Ltd	Wuhan Hubei, CN
2050012	BECKMAN COULTER, INC.	BREA, CA, US
1063851	MERCEDES MEDICAL LLC	Lakewood Ranch, FL, US
1000303355	SAKURA SEIKI CO., LTD.	CHIKUMA-CITY Nagano, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1831638. Last updated year: 2026. Please use registration number 1831638 when referencing this establishment in official correspondence.