Amersham Corp.

United StatesFDA 510(k) applicant, unverified

Devices: 94

What Amersham Corp. makes

Amersham Corp. manufactures in vitro diagnostic assays, including lateral flow and test kits for thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin, and anti-double-stranded DNA (anti-DSDNA). The company also produces radiopharmaceutical sources like gadolinium-153 for bone densitometry and cesium-137 microseed assemblies for medical imaging and brachytherapy applications.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. These products are intended for laboratory and clinical use in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue94

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What Amersham Corp. makes

Catalogue94

Amerlex-M Luteinizing Hormone Radioimmuno-Kit Ref K851104

Amerlite Reproductive Endocrinology Control Sera Ref K882736

Gadolinium-153 Bone Densitometer (GDC.10413) Ref K901857

Amerlex Human Placental Lactogen Ref K840588

Amerlex-M Progesterone Radioimmunoassay Kit Ref K864855

Amerlex B-Lcg Ria Kit Ref K821031

Amerlite Estradiol Assay, LAN.2080 (144 Test Kit) Ref K884105

Tsh Ria Kit Ref K780726

Ferritin Ria Kit Ref K800299

Amerlite TT4 Assay (240/480/144 Test Kits) Ref K873976

Code QAS.105 Prolactin Control Sera Ref K800708

Glycosylated Hemoglobin Kit Ref K801561

Vitamin B12/Folate Dual Radioassay Kits Ref K812979

Amerlite Tsh-60 Assay Product Code: Lan. 0008/2008 Ref K904666

Amerlite Ferritin Assay (Additional Protocol) Ref K892362

Amerlex-M T3 Ria Kit For Serum And Plasma Ref K860252

Gadolinium-153 Bone Densitometer (GDC.10411/10412) Ref K901854

Code Qas 103 Anti-Dna Controls Ref K791354

Amerlite T3U Assay LAN.0004/1004/2004, 240/480/144 Ref K874362

Amerlex-M Tsh Ria Ref K842948

Digoxin & Phenytoin Control Sera Ref K803097

Radioassay Kit, IM.72 Fsh Ref K760373

Ob-Gyn Control Sera (Code 196300) Ref K761309

Radioassay Controls 31 & 32, Anti-Dsdna Control Ref K894329

Amerlite TT3 Assay, LAN.0003/2003 240/144 Kit Ref K881373

Ferritin Ria Kit Ref K811804

Amerlite Estradiol-60 Assay LAN.0081/2081 Ref K896270

Amerlex-M Follicle Stimulating Hormone(Fsh)Radioim Ref K851361

Amerlite Hcg-60 Assay, LAN.0083/2083 240KIT/144KIT Ref K881355

Vitamin B12 Radioassay Ref K780799

Amerlex-M Progesterone Radioimmunoassay Kit Code Ref K845026

Amerlite Prolactin Assay, LAN.0078/2078(240/144) Ref K883878

Amerliite FT4 Assay LAN.0006/2006 240/144 Test Kit Ref K883123

Amerlex-M Camp(125)Assay System RPA.508 (100 Kit) Ref K860253

Amerlite Rubella Antibody Assay, LAN.0200/2200 Ref K882475

Amerlex Cortisol Ria Kit Ref K800700

Phenytoin Ria Kit Ref K770779

Amerlite Total Thyroid Control Sera LAN.4001 Ref K882727

Amerlite Tbg Assay, LAN.0005/1005 240/144 Test Kit Ref K893469

Gadolinium-153 Bone Densitometer Sources GDC.10415 Ref K901832

Amerlex-Mab FT4 Kit Ref K894091

Prostatic Acid Phosphatase (Pap) Rda Kit Ref K811169

Amersham Tsh Control Sera Ref K902760

Amerlex Tsh Ria Kit Ref K812136