OC-Light S

GUDID 00816917025704

Personal Use Kit OC-Light S, for Missouri Baptist Med Ctr

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816917025704
NIH Device Record Key4e808a5e-e542-4b0b-8647-94f8fbd24e43
Commercial Distribution StatusIn Commercial Distribution
Brand NameOC-Light S
Version Model NumberFBPUS-MBAP
Company DUNS078413594
Company NamePOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816917025704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-18
Device Publish Date2022-04-08

On-Brand Devices [OC-Light S]

00816917024578Personal Use Kit OC-Light S, Custom Kit for Melrose Wakefield Hosp
00816917024561Personal Use Kit OC-Light S, Custom Kit for Community Hospitals & Wellness Centers - Cardinal
00816917024554Personal Use Kit OC-Light S, Custom Kit for Froedtert Health Medical Group
00816917024509Personal Use Kit OC-Light S for ADL
00816917024493Personal Use Kit OC-Light S for ARMC
00816917024431OC-Light S Personal Use Kit for VA1
00816917023861Personal Use Kit OC-Light S, Custom Kit for Eskenazi
00816917023854Personal Use Kit OC-Light S, Custom Kit for Shands Jksn
00816917023847Personal Use Kit OC-Light S, Custom Kit for Lawndale CHC
00816917023830Personal Use Kit OC-Light S, Custom Kit for Flgler Med Ass
00816917023823Personal Use Kit OC-Light S, Custom Kit for Mldn Fam MC
00816917023816Personal Use Kit OC-Light S, Custom Kit for Froedtert Health Medical Group
00816917023809Personal Use Kit OC-Light S, Custom Kit for Cambridge Care Center
00816917023793Personal Use Kit OC-Light S, Custom Kit for Elkhart Clinic
00816917023786Personal Use Kit OC-Light S
00816917023779Personal Use Kit OC-Light S, Clinical Associates
00816917023762Personal Use Kit OC-Light S, Addressed
00816917023755Personal Use Kit OC-Light S, Amarillo Family
008169170237486 Personal Use Kits OC-Light S
008169170237316 Personal Use Kits OC-Light S
008169170237246 Personal Use Kits OC-Light S
00816917023656Personal Use Kit OC-Light S, Custom Kit for Assured Imaging
00816917023649Personal Use Kit OC-Light S for St. Joseph Mrcy Oklnd
00816917023632Personal Use Kit OC-Light S, Custom Kit for NBRMPS
00816917023625Personal Use Kit OC-Light S, Custom Kit for ABRMPS
00816917023618Personal Use Kit OC-Light S, Custom Kit x 6
00816917022963Personal Use Kit OC-Light S, Custom Kit for W.A. Foote Hospital
00816917022956Personal Use Kit OC-Light S, Custom Kit for Prima Care Lab
00816917022949Personal Use Kit OC-Light S, Custom Kit for Alameda Health System
00816917022857Personal Use Kit OC-Light S, FBPUS for Harris Health System
00816917020907Personal Use Kit OC-Light S, Custom Kit for (Cambridge Care Center) Somerville Pediatrics
00855574005346Personal Use Kit OC-Light S
00855574005339Starter Pack OC-Light S
00855574005322Test Kit OC-Light S
00855574005315Sampling Bottles OC-Light S
00855574005308OC-Light S Test Strips
00855574005193Personal Use Kit Bulk, OC-Light S
00816917024820Personal Use Kit OC-Light S, Custom Kit for Albany Area Primary Healthcare, Inc.
00816917024813Personal Use Kit OC-Light S, Custom Kit for St. Charles Health System
00816917024806Personal Use Kit OC-Light S, Custom Kit for Guthrie Robert Packer Hospital
00816917024790Personal Use Kit OC-Light S, Custom Kit for (CHA) Cambridge Primary Care Center
00816917024783Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Health Center (Froede
00816917025001Personal Use Kit OC-Light S, Custom Kit for Lexington Clinic, PSC
00816917025056Personal Use Kit OC-Light S, for Olympic Medical Center
00816917024592Personal Use Kit OC-Light S, Custom Kit for Bronson Methodist Hospital Laboratory
00816917025087Personal Use Kit OC-Light S, for Alverno Labs
00816917025063Personal Use Kit OC-Light S, for Venice Family Clinic
00816917025223Personal Use Kit OC-Light S, for Lebauer Healthcare Cone Health
00816917025506Personal Use Kit OC-Light S, for Monument Health
00816917025582Personal Use Kit OC-Light S, for Goshen Health

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