MedtechSourcebook

Reagents, Specific, Analyte (MVU) contract manufacturers

10 US facilities list FDA product code MVU as a contract manufacturer (10) or contract sterilizer (0).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Reagents, Specific, Analyte
Product code
MVU (FDA product classification database)
Device class
Class I
Regulation
21 CFR 864.4020
Classification panel
Pathology

Where they are

California 5 · Colorado 1 · Florida 1 · Massachusetts 1 · North Carolina 1 · Puerto Rico 1

All 10 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Advanced Cell Diagnostics, Inc.3009161685Contract manufacturerPathologyNewark, CANot verifiedOct 21, 2026
ANTIBODIES INCORPORATED2914537Contract manufacturerHematology; PathologyDavis, CANot verifiedOct 21, 2026
BAEBIES INC.3011240982Contract manufacturerClinical chemistry; PathologyDurham, NCNot verifiedOct 21, 2026
BECKMAN COULTER, INC.1017835Contract manufacturerHematology; PathologyHialeah, FLNot verifiedOct 21, 2026
Becton Dickinson Caribe, LTD3008352382Contract manufacturerHematology; Pathology; ImmunologyCayey, PRNot verifiedOct 21, 2026
BIO SB, INC.3008773547Contract manufacturerHematology; Microbiology; PathologySanta Barbara, CANot verifiedOct 21, 2026
CALBIOTECH, INC.2090110Contract manufacturerMicrobiology; Immunology; PathologyEl Cajon, CANot verifiedOct 21, 2026
CELL MARQUE CORP.1649339Contract manufacturerPathology; HematologyRocklin, CANot verifiedOct 21, 2026
Cellay, Inc.3007738260Contract manufacturerPathologyCambridge, MANot verifiedOct 21, 2026
ROCKY MOUNTAIN REAGENTS, INC.1711690Contract manufacturerPathologyGolden, CONot verifiedOct 21, 2026

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