FDA.reportPublic FDA data

UNISTAT® Bilirubinometer Specimen Cuvettes

Primary DI
00812559011143
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126650253
Device count
51
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
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
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
00812559011136UNISTAT® 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