Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1210083

FEI Number

1210083

Entity Name

ANALYTICHEM USA, INC.

City/State/Country

Winslow, ME, US

Establishment Address

227 China Road, Winslow, ME 04901, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AnalytiChem USA, Inc. (Owner Number: 1210083)

Owner / Operator Contact Address

227 CHINA RD., P.O. BOX 788, Waterville, ME 04903, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MIO Medium Bordet Gengou w/ 15% Sheep Blood K-V Laked Anaerobic Agar Selective Strep Modified SDA w/ Chloramphenicol Columbia CNA w/ 5% Sheep Blood Campy BAP Agar PEA Agar w/o Sheep Blood PDA w/ Tartaric Acid PEA Agar w/ 5% Sheep Blood Saline 0.85% Saline 0.45% Sterile Screw Cap Nitrate Reagent B Nitrate Reagent A Voges-Proskauer Reagent B Methyl Red Indicator Voges-Proskauer Reagent A OXI-Test Reagent Kovac's Reagent SDA Nutrient Agar BHI Agar Slant Peptone Water BHI Agar Brucella Agar Tryptic Soy Agar Brucella Agar Slant Potato Dextrose Agar OFPBL Agar Potato Dextrose Slant Anaerobic Blood Agar Nutrient Agar Slant TSA Slant Cooked Meat Medium Cooked Meat w/ Dextrose, Hemin, Vitamin K Columbia CNA w/ 5% Sheep Blood Chocolate Agar Sterilized Water Tryptic Soy Broth Nutrient Broth Purple Broth Base w/ Dextrose Fluid Thioglycollate Medium w/o Indicator Fluid Thio. w/o Indicator w/ Hemin & Vitamin K Fluid Thioglycollate Medium BHI Broth TSA 5% Sheep Blood / MacConkey Agar Moeller Decarboxylase Broth w/o Carb Simmons Citrate Agar Ureaplasma Broth Tryptic Soy Agar w/ 5% Sheep Blood Nutrient Gelatin Deep Motility Test Medium w/ TTC Tryptic Soy Agar w/ 5% Sheep Blood / CLED Agar LIA Slant Ureaplasma Agar TSI Slant Kligler Iron Agar Slant Urea Agar Slant Motility Test Agar Simmons Citrate Slant Lecithin Lactose Agar Phenol Red Broth w/ Lactose XLD Agar TSA w/ 5% Sheep Blood & Esculin Cetrimide Agar Phenol Red Broth w/ Sucrose TCBS Agar Yersinia Selective Agar Bile Esculin Agar EMB Agar Pseudomonas Isolation Agar Hektoen Enteric Agar MacConkey Agar Brilliant Green Agar Colorex Strep ACG Vogel Johnson Agar Dermatophyte Test Medium Phenol Red Broth w/ Dextrose Colorex Strep A Phenol Red Broth w/ Mannitol Sorbitol MacConkey Agar Mannitol Salt Agar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSE	Culture Media, Multiple Biochemical Test	Microbiology	Class 1	866.2320	1992-08-06
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	1992-08-06
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2023-07-25
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-01-24
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2018-12-17
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	1992-08-06
KZI	Culture Media, Enriched	Microbiology	Class 1	866.2330	2018-12-17
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2018-12-17
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	1992-08-06
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	1992-08-06
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2018-12-17

Official Correspondent

Melissa Higgins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AnalytiChem USA, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834001	Micro Media Laboratories	KLIGLER IRON AGAR	1983-12-22
K863524	Bd Becton Dickinson Vacutainer Systems Preanalytic	REGAN-LOWE CHARCOAL AGAR	1986-09-19
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30
K790620	Anaerobe Systems	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	1979-04-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-05	Remel, Inc.	1	Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

Similar Registrations

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1924669	REMEL, INC.	LENEXA, KS, US
3015715780	LEGACY BIOLOGICALS	Baltimore, MD, US
9610649	MEDICAL WIRE AND EQUIPMENT CO. LTD.	CORSHAM, WILTSHIRE, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1210083. Last updated year: 2026. Please use registration number 1210083 when referencing this establishment in official correspondence.