BAYER HEALTHCARE, LLC - MISHAWAKA, IN

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FDA-Registered Company Profile for BAYER HEALTHCARE, LLC

FDA-Supplied Establishment Information:

Establishment Registration Number:

1826988

Company Name:

BAYER HEALTHCARE, LLC

Address:

430 SOUTH BEIGER ST.

Address 2:

City:

MISHAWAKA

State

Zip / Postal Code:

46544

County:

ST JOSEPH

Country:

Establishment Operation Code(s):

AA - Initial Distributor
MM - Manufacturer
MS - Specification Developer
RR - Repackager/Relabeller

Establishment Status Code:

A - Active

Year of Most Recent Initial
or Annual Registration:

2007

FDA-Supplied Owner/Operator Information:

Owner/Operator Number:

2425130

Company Name:

BAYER HEALTHCARE, LLC

Address:

555 WHITE PLAINS RD.

Address 2:

5TH FLOOR

City:

TARRYTOWN

State:

Zip / Postal Code:

10591

Country:

Owner/Operator Phone:

914-524-2955

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MR. CHESTER MCCOY

Company Name:

BAYER HEALTHCARE LLC, DIABETES CARE DIVISION

Address:

430 S.BEIGER ST.

Address 2:

City:

MISHAWAKA

State:

Zip / Postal Code:

46544

Country:

Official Corespondent Phone Number:

574-256-3430

Other Establishment Information:

Establishment Phone:

Fax:

General Email:

Web Site:

Company Brochure:

Keywords:

Company Description:

Services Offered:

About Us:

Differentiation:

FDA-Registered Products Offered by BAYER HEALTHCARE, LLC
	Common Device Name	Proprietary Device Name
1	ASSAY, GLYCOSYLATED HEMOGLOBIN	METRIKA A1CNOW+
2	AUTOMATED URINALYSIS SYSTEM	CLINILAB AUTOMATED URINALYSIS SYSTEM
3	CALIBRATOR	NO PROPRIETARY NAME LISTED
4	CALIBRATOR	NO PROPRIETARY NAME LISTED
5	CALIBRATOR	NO PROPRIETARY NAME LISTED
6	CONTROL MATERIALS	DEX ESPIRIT DEXTER Z CONTROLS
7	CONTROL MATERIALS	NO PROPRIETARY NAME LISTED
8	DATA MANAGEMENT SYSTEMS	GLUCOFACTS DATA MANAGEMENT SYSTEMS
9	DYE AND CLINICAL SOLUTION STAINS	HEMA-TEK STAIN PAKS
10	HEMATOLOGIC SLIDE STAINER	HEMA-TEK AUTOMATED SLIDE STAINER;HEMA-TEK II AUTOMATED SLIDE STAINER; STAIN PACS
11	LANCET, BLOOD	ASCENSIA MICROLET LANCET
12	MULTIPLE	MULTIPLE PRODUCT NAMES
13	MULTIPLE	MULTIPLE PRODUCT NAMES
14	MULTIPLE	MULTIPLE PRODUCT NAMES
15	SPECTROPHOTOMETER	DCA 2000 ANALYZER
16	TEST FOR BLOOD GLUCOSE	GLUCOMETER ENCORE TEST STRIPS
17	TEST FOR CANDIDA SPECIES IN VAGINAL SPECIMENS	MICROSTIX CANDIDA
18	TEST FOR ETHOSUXIMIDE IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
19	TEST FOR GENTAMICIN IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
20	TEST FOR GLUCOSE & KETONES IN URINE	KETO DIASTIX
21	TEST FOR GLUCOSE IN BLOOD	ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS
22	TEST FOR LEUKOCYTES IN URINE	LEUKOSTIX REAGENT STRIPS
23	TEST FOR LEUKOCYTES,NITRITE,BLOOD,PH,CREATININE,SG,KETONE,PROTEIN LOW/HIGH,	MULTISTIX PRO 10 LS
24	TEST FOR NAPA [N-ACETYLPROCAINAMIDE] TEST KIT	NO PROPRIETARY NAME LISTED
25	TEST FOR NETILMICIN IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
26	TEST FOR OCCULT BLOOD IN FECES	HEMATEST
27	TEST FOR PH, PROTEIN, GLUCOSE, KETONE, BILIRUBIN & BLOOD IN URINE	BILILABSTIX
28	TEST FOR PRIMIDONE IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
29	TEST FOR PROCAINAMIDE IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
30	TEST FOR REDUCING SUGARS IN URINE	CLINITEST REAGENT TABLETS
31	TEST FOR TOBRAMYCIN IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
32	TEST FOR UREA NITROGEN IN WHOLE BLOOD	AZOSTIX
33	TEST FOR UROILNOGEN IN URINE	UROBILISSTIX
34	TEST FOR VALPROIC ACID IN SERUM OR PLASMA	NO PROPRIETARY NAME LISTED
35	THREE WAY TEST FOR BACTERIURIA IN URINE	MICROSTIX-3
36	URINALYSIS CONTROLS	CHEK-STIX URINALYSIS CONTROLS
37	VARIOUS INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) PRODUCTS	CMBSTIX
All FDA-Registered products for this company are displayed above.

Other Products Offered by BAYER HEALTHCARE, LLC:

No products have been listed by this company.

Services Offered by the BAYER HEALTHCARE, LLC:
No services have been listed by this company.

Additional Contact Information for BAYER HEALTHCARE, LLC:
There is no additional contact information for this company.

FDA-Registered Company Profile for BAYER HEALTHCARE, LLC

FDA-Registered Products Offered by BAYER HEALTHCARE, LLC

Other Products Offered by BAYER HEALTHCARE, LLC:

Services Offered by the BAYER HEALTHCARE, LLC:

Additional Contact Information for BAYER HEALTHCARE, LLC:

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