FDA.reportPublic FDA data

UNISTAT® Bilirubinometer Specimen Cuvettes

Primary DI
00812559011136
Brand
UNISTAT® Bilirubinometer Specimen Cuvettes
Company
REICHERT, INC.
Model
13102140
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQMBilirubin (Total And Unbound) In The Neonate Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922770000UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311Leica, Inc.1992-08-18MQM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812559011136PrimaryGS10
00812559011143Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559011136008125590111368125590111360812559011136
00812559011143008125590111438125590111430812559011143

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser cuvette IVD, single-useA small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.

Regulatory Flags#

DUNS number
126650253
Device count
51
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812559010580PDM Digital PD Meter150202025-08-12
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010566TS75 Trial Lens150152025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12
00812559011730Phoropter VRx162422025-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812559011143UNISTAT® Bilirubinometer Specimen CuvettesREICHERT, INC.MQM2025-08-12
00380740167561ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167578ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167585AlinityABBOTT IRELANDMQM2024-08-15
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSMQM2024-07-01
00884838096578BiliChekPhilips Medical Systems HsgMQM2022-10-21
30884838096579BiliChekPhilips Medical Systems HsgMQM2022-10-21
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.MQM2020-04-15
00380740174965ARCHITECTAbbott GmbHMQM2020-04-12
00380740174972ARCHITECTAbbott GmbHMQM2020-04-12
00380740158415AlinityAbbott GmbHMQM2019-01-02
00380740158422AlinityAbbott GmbHMQM2019-01-02
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSMQM2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSMQM2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSMQM2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSMQM2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSMQM2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSMQM2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSMQM2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSMQM2018-09-21
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSMQM2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSMQM2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSMQM2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSMQM2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSMQM2018-09-21
08426950807544GEM Premier 5000 PAK BG/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807568GEM Premier 5000 PAK BG/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24