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 IN
Zip / Postal Code: 46544
County: ST JOSEPH
Country: US
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: NY
Zip / Postal Code: 10591
Country: US
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: IN
Zip / Postal Code: 46544
Country: US
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.


Companies Related to BAYER HEALTHCARE, LLC

 Our records indicate that the following companies are related by ownership.


  Company Name Address City State Zip Country
1 BAYER HEALTHCARE LLC 555 WHITE PLAINS RD.
5TH FLOOR 		TARRYTOWN NY 10591 US






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